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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 2,881–2,900 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94

by Denver Solutions, LLC DBA Leiters Health

Reason
CGMP DEVIATIONS
Recall initiated
February 21, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States including VA or other Government facilities

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82

by Denver Solutions, LLC DBA Leiters Health

Reason
CGMP DEVIATIONS
Recall initiated
February 21, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States including VA or other Government facilities

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

by Denver Solutions, LLC DBA Leiters Health

Reason
CGMP DEVIATIONS
Recall initiated
February 21, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States including VA or other Government facilities

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

by Denver Solutions, LLC DBA Leiters Health

Reason
CGMP DEVIATIONS
Recall initiated
February 21, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States including VA or other Government facilities

View recall →

Drug Recall Terminated Historical recordClass II

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60

by Teva Pharmaceuticals USA Inc

Reason
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall initiated
February 22, 2023
Reported by FDA
March 15, 2023
Distribution
CA

View recall →

Drug Recall Ongoing Historical recordClass II

NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0

by Nutraceutical Corporation

Reason
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall initiated
February 23, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA

by Nutraceutical Corporation

Reason
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall initiated
February 23, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2

by Nutraceutical Corporation

Reason
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall initiated
February 23, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9

by Nutraceutical Corporation

Reason
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall initiated
February 23, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.

by Amerisource Health Services LLC

Reason
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Recall initiated
January 27, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

by Sagent Pharmaceuticals Inc

Reason
Labeling: Not elsewhere classified
Recall initiated
February 28, 2023
Reported by FDA
March 15, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

by B. Braun Medical Inc

Reason
Subpotent Drug: low Anti-Factor IIa potency.
Recall initiated
March 1, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

by Apotex Corp.

Reason
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Recall initiated
March 1, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4

by The Harvard Drug Group

Reason
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Recall initiated
February 23, 2023
Reported by FDA
March 8, 2023
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.