Recalls & alerts

171 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · September 9, 2026Moderate risk

  Lexia LLC : Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN,…

  Broadway Joe's Pain Cream, a topical cream containing histamine dihydrochloride, CBD isolate, and hempseed oil, is recalled. The hazard is potential contamination of raw material, exposing consumers who use the product in Colorado. Consumers should stop using the product and follow the firm's voluntary recall instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter…

  Baxter Healthcare Corporation’s Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL single-dose infusion bags are affected. The hazard is manufacturing practice deviations, exposing patients who receive this sterile injection to potential quality and safety risks. Consumers should stop using the product and contact their healthcare provider or pharmacy for instructions.

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• openFDA · September 9, 2026Moderate risk

  Allies Group Inc. : THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed…

  The recall affects THE ONE SPF 50 Invisible Sunscreen Gel by Allies Group. The product may not reliably provide the SPF 50 protection stated on the label, exposing users to risk of sunburn and skin damage. Consumers should stop using this sunscreen and not rely on it for sun protection.

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• openFDA · September 9, 2026Moderate risk

  Allies Group Inc. : THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the…

  The affected product is The One SPF 50 Invisible Sunscreen Gel, distributed by Allies Group Inc., in single-use 3ml sachets. The sunscreen may not reliably provide SPF 50 protection, exposing users to increased risk of sunburn. Consumers should stop using the affected product.

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• openFDA · September 9, 2026Moderate risk

  Teva Pharmaceuticals USA, Inc : traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva…

  Teva Pharmaceuticals is recalling traZODone Hydrochloride Tablets, USP, 50 mg, 100-count bottles. The tablets may contain foreign tablets or capsules, posing a risk to consumers nationwide. Consumers should not use the affected tablets and should follow the recall instructions.

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• openFDA · September 9, 2026Low risk

  Supernus Pharmaceuticals, Inc. : Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA,…

  Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) extended-release capsules, 50 mg, 30-count bottles. The capsules failed dissolution specifications, meaning they may not release the drug properly, affecting patients nationwide who use this prescription. Consumers should stop using the recalled capsules and return them to their pharmacy or contact their doctor for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and…

  Baxter Healthcare is recalling CARDENE IV (Nicardipine Hydrochloride) injection in 0.83% Sodium Chloride, 40 mg per 200 mL, in GALAXY single-dose containers. The recall is due to manufacturing quality deviations (CGMP), which may pose a risk to patients receiving this intravenous drug. Consumers should stop using the product and contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic,…

  Baxter Healthcare Corporation is recalling Daptomycin in 0.9% Sodium Chloride Injection, 1000 mg per 100 mL, in single dose containers. The product may have quality problems from manufacturing deviations, which could harm patients receiving this sterile injectable drug. Consumers should stop using the recalled product and contact their doctor or pharmacist for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare…

  Baxter Healthcare Corporation is recalling Vasopressin in 0.9% Sodium Chloride Injection, 20 units per 100 mL, 100mL single-dose containers. The recall is due to manufacturing quality deviations, which may expose patients in the US, Puerto Rico, and Chile to health risks. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…

  Baxter Healthcare Corporation is recalling Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL, in GALAXY 50 mL single-dose containers. The recall follows manufacturing deviations that may affect sterility or drug strength, exposing patients nationwide, in Puerto Rico, and in Chile to potential harm. Patients should stop using the recalled product, return it to the pharmacy, and contact their healthcare provider for guidance.

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• openFDA · September 2, 2026Moderate risk

  Apotex Corp. : Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured…

  The recall affects Paxil CR (paroxetine) extended-release tablets, 37.5mg, 30-count bottles, made by Apotex Corp. The tablets failed dissolution and 24-month stability tests, so they may not dissolve properly, and patients nationwide are exposed. Consumers should stop using the recalled tablets and contact their pharmacist or doctor for guidance.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 112 mcg, 1000-count bottles. The tablets may be subpotent, posing a health risk to patients who take this thyroid medication. Consumers should check their bottles and follow the recall instructions.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 88 mcg, 1000-count bottles. The tablets are subpotent, meaning they may not work as intended, affecting patients who take this thyroid medication. Consumers should stop using the recalled bottles and return them to their pharmacy or consult their healthcare provider.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only,…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) in 90-count and 1000-count bottles. The tablets are subpotent, meaning they may contain less active ingredient than labeled, affecting patients who take this thyroid medication. Consumers should follow the recall instructions provided by the FDA or their pharmacy.

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• openFDA · September 2, 2026High risk

  B BRAUN MEDICAL INC : Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00

  B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP, 1000 mL EXCEL containers. The IV solution may contain particulate matter, posing a risk of injury to patients who receive it. Consumers should stop using the recalled product and return it to their pharmacy or contact B. Braun Medical for instructions.

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• openFDA · September 2, 2026High risk

  Fresenius Kabi USA, LLC : Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC…

  Fresenius Kabi USA is recalling Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL, 20 mL vials. The vials contain glass particles, posing a risk to patients who receive the injection. Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 175 mcg, in 90-count and 1000-count bottles. The tablets are subpotent, meaning they contain less active ingredient than expected, which can affect patients who take this thyroid medication. Consumers should check their bottles for the affected NDC numbers listed in the recall.

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• openFDA · September 2, 2026Moderate risk

  Church & Dwight Co., Inc. : Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church &…

  Church & Dwight Co. Inc. is recalling Zicam Cold Remedy Medicated Nasal Swabs with Cooling Menthol & Eucalyptus, 20 single-use swabs per carton. The swabs may be contaminated because microbiological testing showed out-of-limit results, posing a risk to consumers nationwide. Consumers should stop using the recalled swabs and follow the firm's recall instructions for return or disposal.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare is recalling Levothyroxine Sodium Tablets, USP, 150 mcg, in 1000-count bottles. The tablets may be subpotent, meaning patients may not receive the full dose, posing a risk to those with thyroid conditions. Consumers who have this medication should stop using it and contact their pharmacy or healthcare provider for a replacement.

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• openFDA · September 2, 2026Moderate risk

  Mallinckrodt Hospital Products Inc. : Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 &…

  Mallinckrodt Hospital Products Inc. is recalling Acthar Gel (repository corticotropin injection) 5 mL multiple-dose vials. The vials may contain glass and stopper particles, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 75 mcg, 1000-count bottles. The tablets are subpotent, posing a risk to patients who take this thyroid medication. Consumers should stop using the recalled bottles and consult their pharmacist or doctor.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by:…

  Accord Healthcare is recalling Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles. The tablets may be subpotent, meaning patients taking them may not receive the full dose. Consumers should check their bottles and contact their pharmacist or healthcare provider for guidance.

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• openFDA · September 2, 2026Moderate risk

  Lupin Pharmaceuticals Inc. : Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by:…

  Lupin Pharmaceuticals Inc. is recalling Clobetasol Propionate Cream USP, 0.05%, 60 g tubes, prescription only. The cream failed content uniformity specifications, affecting patients who use the product. Consumers should stop using the recalled tubes and return them to the pharmacy.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only,…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 137 mcg, in 90-count and 1000-count bottles. The tablets may be subpotent, meaning patients may not receive the full intended dose of thyroid hormone. Consumers should stop using the affected product and contact their pharmacist or healthcare provider for instructions.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 25 mcg, 1000-count bottles. The tablets may be subpotent, meaning they contain less active ingredient than expected, which can affect patients who rely on this thyroid medication. Consumers should stop using the recalled bottles and return them to their pharmacy or contact their doctor for a replacement.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 125 mcg, in 1000-count bottles, distributed nationwide in the United States. The tablets may be subpotent, meaning patients may not receive the full dose of their thyroid medication, posing a health risk to those who take it. Consumers should stop using the affected bottles and return them to the pharmacy or contact their healthcare provider for guidance.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured…

  Accord Healthcare is recalling Levothyroxine Sodium Tablets, USP, 50 mcg, in 1000-count bottles. The tablets may be subpotent, meaning patients may not receive the full dose of thyroid hormone. Consumers should stop taking the recalled bottles, check the NDC 16729-448-17, and return them to their pharmacy for a replacement.

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• openFDA · September 2, 2026Moderate risk

  Hikma Pharmaceuticals USA INC. : Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan…

  Hikma Pharmaceuticals is recalling its Ramipril Capsules USP, 10 mg, sold in 100 and 500 capsule bottles. The capsules contain an impurity called dicyclohexylurea that fails degradation specifications, posing a risk to patients taking them. Consumers should stop using the recalled capsules and contact their pharmacist or the manufacturer for instructions.

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• openFDA · September 2, 2026Moderate risk

  ACCORD HEALTHCARE, INC. : Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only,…

  Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg) in 90-count and 1000-count bottles. The tablets may be subpotent, meaning they contain less active ingredient than expected, which can affect patients who rely on this thyroid medication. Consumers should check their bottle's NDC and lot number and contact their pharmacist or doctor for guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx…

  American Regent, Inc. is recalling Tralement (trace elements injection 4*, USP) in 1mL and 5x1mL single dose vials. The vials may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC…

  American Regent, Inc. is recalling Cyanocobalamin injection USP, 1,000 mcg/mL, in 1 mL multi-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients who receive the injection. Consumers should stop using the recalled vials and contact their healthcare provider or the company for instructions.

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• openFDA · August 26, 2026Moderate risk

  SUN PHARMACEUTICAL INDUSTRIES INC : Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed…

  Taro Carbamazepine Tablets, USP, 200mg, in 1000-count bottles, are affected. The tablets may contain black spots from burnt excipient, posing a risk to patients taking them. Consumers should stop using the affected tablets and return them to their pharmacy.

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• openFDA · August 26, 2026High risk

  Fresenius Kabi USA, LLC : Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake…

  Fresenius Kabi is recalling Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes. The syringe labeled as morphine may actually contain Dilaudid, exposing patients to a different, more potent opioid. Consumers should stop using the recalled syringes and return them to their pharmacy or healthcare provider.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose…

  American Regent, Inc. is recalling Selenious Acid Injection, USP 12 mcg/2 mL, a prescription drug for intravenous use. The product may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for instructions.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE…

  American Regent, Inc. is recalling Aminocaproic Acid Injection, USP, 250 mg/mL in 20 mL multiple dose vials. The vials may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients receiving IV infusion. Consumers should stop using the recalled vials, return them to the pharmacy, and contact their healthcare provider for guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials…

  American Regent, Inc. is recalling niCARdipine Hydrochloride Injection, USP, 25 mg/10mL, in single-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients receiving the injection. Consumers should stop using the recalled vials and contact their pharmacist or American Regent for instructions.

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• openFDA · August 26, 2026Moderate risk

  Shilpa Medicare Limited : PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India;…

  PEMRYDI RTU (pemetrexed injection) 500 mg/50 mL single-dose vials, distributed by Amneal Pharmaceuticals, are affected. The vials may contain a green to dark green discolored solution, posing a risk to patients receiving this prescription injection. Consumers should not use the recalled vials and should contact their healthcare provider or pharmacy.

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• openFDA · August 26, 2026Moderate risk

  Mylan Pharmaceuticals Inc : Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc.,…

  Mylan Pharmaceuticals Inc. is recalling Acamprosate Calcium Delayed-Release Tablets, 333 mg, in 180-tablet bottles. The tablets fail dissolution specifications, which may affect patients taking this prescription medication. Consumers should contact their pharmacist or healthcare provider for guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN…

  American Regent, Inc. is recalling nitroglycerin injection, USP, 50 mg/10 mL, in 10 mL vials. The product contains particulate matter such as hair, glass, and paraformaldehyde, posing a safety risk to patients who receive the injection. Consumers should stop using the recalled vials and contact their healthcare provider or pharmacy for instructions on returning the product.

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• openFDA · August 26, 2026Moderate risk

  Regeneron Pharmaceuticals Inc : Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron…

  Regeneron Pharmaceuticals is recalling Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL, a prescription drug for intravenous infusion. The product may lack assurance of sterility, posing a risk of infection to patients who receive it. Patients should stop using the recalled product and contact their doctor or pharmacist for guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose…

  American Regent, Inc. is recalling Atropine Sulfate injection, USP, 1 mg/mL, in single-dose vials. The product may contain hair, glass, or paraformaldehyde particles, posing a risk to patients given the drug intravenously. Consumers should stop using the recalled vials and follow the company's recall instructions.

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• openFDA · August 26, 2026Moderate risk

  Shilpa Medicare Limited : PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India;…

  The recall affects PEMRYDI RTU (pemetrexed injection) 100 mg/10 mL single-dose vials, distributed by Amneal Pharmaceuticals. Certain vials contain a green to dark green discolored solution, posing a risk to patients who receive this injectable drug. Consumers should stop using the affected vials and contact their healthcare provider or pharmacy for replacement and guidance.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC…

  American Regent, Inc. is recalling Acetylcysteine Solution, USP, 10% (100 mg/mL) in 4 mL and 25x4 mL vials labeled NOT FOR INJECTION. The solution may contain particulate matter including hair, glass, and paraformaldehyde, posing a risk to patients who use it. Consumers should stop using the recalled product and contact American Regent for return instructions.

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• openFDA · August 26, 2026High risk

  American Regent, Inc. : Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC…

  American Regent, Inc. is recalling Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL) single-dose vials. The injection contains glass and/or paraformaldehyde particulate matter, posing a risk to patients who receive it. Consumers should stop using the recalled vials and contact their healthcare provider or pharmacist for instructions.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC…

  American Regent, Inc. is recalling Acetylcysteine Solution, USP, 20% (200 mg/mL) in 4 mL vials, sold as single vials and 25-vial packs. The solution may contain particulate matter including hair, glass, or paraformaldehyde, posing a risk to patients who use it. Consumers should stop using the recalled vials and return them to the pharmacy or contact American Regent for a refund or replacement.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials…

  American Regent, Inc. is recalling Multrys (Trace Elements Injection 4, USP) 1 mL single-dose vials. The product contains particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients receiving intravenous infusion. Consumers should stop using the recalled vials and contact their pharmacist or healthcare provider for further instructions.

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• openFDA · August 26, 2026Moderate risk

  Golden State Medical Supply Inc. : Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro…

  Golden State Medical Supply Inc. is recalling Carbamazepine Tablets, USP, 200mg, in 100-count and 1000-count bottles. The tablets may contain black specks, posing a risk to patients taking this prescription drug. Consumers should stop using the recalled tablets and return them to their pharmacy or contact their healthcare provider.

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• openFDA · August 26, 2026Moderate risk

  American Regent, Inc. : Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL…

  American Regent, Inc. is recalling Cyanocobalamin injection USP, 10,000 mcg/10 mL, packaged in 10 mL multi-dose vials. The product may contain particulate matter such as hair, glass, or paraformaldehyde, posing a risk to patients who receive the injection. Consumers should stop using the recalled vials and contact their healthcare provider or pharmacy for instructions.

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• openFDA · August 19, 2026Moderate risk

  Shoolin Pharma Chem LLP : TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near…

  Shoolin Pharma Chem LLP is recalling TADALAFIL USP, a 1 kg bag of bulk drug ingredient for prescription compounding. The product may be contaminated or otherwise compromised due to manufacturing deviations, posing a risk to patients who receive compounded medications made with it. Consumers should contact their pharmacist or healthcare provider to determine if their medication is affected and seek a replacement.

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• openFDA · August 19, 2026Moderate risk

  Shoolin Pharma Chem LLP : SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani…

  Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP, a prescription compounding ingredient sold in 1.00 kg bags. The product may be affected by CGMP deviations found during an FDA inspection, posing a risk to patients who receive compounded medications made with it. Consumers should contact their pharmacist or healthcare provider to determine if their medication is affected and seek guidance.

  drugs

Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.