Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 481–500 of 1,000 recalls

Class IITerminated

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

Accord Healthcare, Inc.

Presence of Particulate Matter: Particulate matter identified as fiber.

July 3, 2023 · DrugView details →
Class IITerminated

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08

Strides Pharma Inc.

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

June 26, 2023 · DrugView details →
Class IITerminated

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Kramer Laboratories, Inc.

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

June 23, 2023 · DrugView details →
Class IITerminated

Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.

Amerisource Health Services LLC

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

June 23, 2023 · DrugView details →
Class IITerminated

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

Kramer Laboratories, Inc.

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

June 23, 2023 · DrugView details →
Class IITerminated

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

The Harvard Drug Group

Packaging defect: blister packaging inadequately sealed.

June 16, 2023 · DrugView details →
Class IITerminated

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03

Ferring Pharmaceuticals Inc

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

June 12, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

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

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →
Class IITerminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

Amneal Pharmaceuticals of New York, LLC

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

May 30, 2023 · DrugView details →
Class IITerminated

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent drug

May 30, 2023 · DrugView details →
← PreviousPage 25 of 50Next →