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FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Jul 3, 2023

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord…

Reason Presence of Particulate Matter: Particulate matter identified as fiber.

Accord Healthcare, Inc. NDC 16729-512-43 D-0917-2023

Class II · Moderate risk Terminated Jun 26, 2023

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences…

Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Strides Pharma Inc. NDC 64380-933-08 D-0895-2023

Class II · Moderate risk Terminated Jun 23, 2023

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer…

Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Kramer Laboratories, Inc. D-0943-2023

Class II · Moderate risk Terminated Jun 23, 2023

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL…

Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Kramer Laboratories, Inc. D-0942-2023

Class II · Moderate risk Terminated Jun 23, 2023

Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…

Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…

Amerisource Health Services LLC NDC 68084-645-01 D-0892-2023

Class II · Moderate risk Terminated Jun 16, 2023

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries…

Reason Packaging defect: blister packaging inadequately sealed.

The Harvard Drug Group NDC 0904-7179-61 D-0878-2023

Class II · Moderate risk Terminated Jun 12, 2023

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal…

Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products

Ferring Pharmaceuticals Inc NDC 55566-6500-03 D-0879-2023

Class II · Moderate risk Terminated Jun 5, 2023

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 69685-112-01 D-0890-2023

Class II · Moderate risk Terminated Jun 5, 2023

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 69685-102-02 D-0889-2023

Class II · Moderate risk Terminated Jun 5, 2023

StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 69685-101-02 D-0888-2023

Class II · Moderate risk Terminated Jun 5, 2023

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 69685-113-16 D-0887-2023

Class II · Moderate risk Terminated Jun 5, 2023

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC…

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 69685-103-16 D-0886-2023

Class II · Moderate risk Terminated Jun 5, 2023

SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 61152-199-99 D-0885-2023

Class II · Moderate risk Terminated Jun 5, 2023

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 55758-001-15 D-0884-2023

Class II · Moderate risk Terminated Jun 5, 2023

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC…

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 55758-035-01 D-0883-2023

Class II · Moderate risk Terminated Jun 5, 2023

Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 55758-036-01 D-0882-2023

Class II · Moderate risk Terminated Jun 5, 2023

Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

Reason cGMP deviations

Homeocare Laboratories, Inc. D-0881-2023

Class II · Moderate risk Terminated Jun 5, 2023

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC…

Reason cGMP deviations

Homeocare Laboratories, Inc. NDC 80551-201-02 D-0880-2023

Class II · Moderate risk Terminated May 30, 2023

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512…

Reason Subpotent drug

Sun Pharmaceutical Industries INC NDC 62756-0233-01 D-0891-2023

Class II · Moderate risk Terminated May 30, 2023

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC…

Reason Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Amneal Pharmaceuticals of New York, LLC NDC 65162-212-10 D-0876-2023

Class II · Moderate risk Terminated May 25, 2023

Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by…

Reason Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

Golden State Medical Supply Inc. NDC 51407-731-25 D-0867-2023

Class II · Moderate risk Terminated May 25, 2023

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx…

Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…

Viatris Inc NDC 0037-9001-05 D-0866-2023

Class II · Moderate risk Terminated May 23, 2023

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA…

Reason Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Fresenius Medical Care Holdings, Inc. NDC 49230-300-10 D-0777-2023

Class II · Moderate risk Terminated May 16, 2023

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park…

Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Alpha Aromatics D-0760-2023

Class II · Moderate risk Terminated May 15, 2023

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC…

Reason Lack of Assurance of Sterility

Astral SteriTech Private Ltd. NDC 70594-080-02 D-0631-2023