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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 4,601–4,620 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

by Teligent Pharma, Inc.

Reason
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Recall initiated
October 12, 2021
Reported by FDA
December 22, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

by Teligent Pharma, Inc.

Reason
Superpotent Drug
Recall initiated
October 12, 2021
Reported by FDA
December 22, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.

by Teligent Pharma, Inc.

Reason
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Recall initiated
October 12, 2021
Reported by FDA
December 22, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

by Preferred Pharmaceuticals, Inc.

Reason
Defective container: Out of specification for container integrity leading to bottles leaking.
Recall initiated
November 29, 2021
Reported by FDA
December 22, 2021
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.

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Drug Recall Terminated Historical recordClass II

VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25

by Apollo Care

Reason
Crystallization: Product appears to be turbid.
Recall initiated
October 28, 2021
Reported by FDA
December 15, 2021
Distribution
MO

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Drug Recall Terminated Historical recordClass II

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.

by Ascent Pharmaceuticals, Inc.

Reason
Product Mix-up
Recall initiated
November 19, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Recall initiated
November 12, 2021
Reported by FDA
December 15, 2021
Distribution
USA Nationwide.

View recall →

Drug Recall Completed Historical recordClass I

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

by American Screening LLC

Reason
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Recall initiated
November 19, 2021
Reported by FDA
December 15, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Completed Historical recordClass I

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

by Sandoz Inc

Reason
Temperature Abuse; temperature excursion during shipping
Recall initiated
November 17, 2021
Reported by FDA
December 8, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

by Pfizer Inc.

Reason
Lack of sterility assurance: bag has the potential to leak.
Recall initiated
November 30, 2021
Reported by FDA
December 8, 2021
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug
Recall initiated
November 19, 2021
Reported by FDA
December 8, 2021
Distribution
nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50

by ASP CARES

Reason
Lack of Assurance of Sterility
Recall initiated
November 17, 2021
Reported by FDA
December 8, 2021
Distribution
United States

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.