Public Health Trace

Get Alerts

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.

Filters

Drug Recall Terminated Historical recordClass II

Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30

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 →

Drug Recall Terminated Historical recordClass II

Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30

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 →

Drug Recall Terminated Historical recordClass III

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05

by Aurobindo Pharma USA Inc.

Reason: Failed Impurities/Degradation Specifications
Recall initiated: November 15, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.

by Teligent Pharma, Inc.

Reason: Defective Container
Recall initiated: October 19, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05

by Teligent Pharma, Inc.

Reason: Defective Container
Recall initiated: October 19, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Recall initiated: September 28, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Recall initiated: September 28, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.

by UNICHEM PHARMACEUTICALS USA INC

Reason: Discoloration
Recall initiated: October 25, 2021
Reported by FDA: December 1, 2021
Distribution: Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

by Bayer Healthcare Pharmaceuticals Inc.

Reason: cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass I

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Chemical Contamination: presence of benzene
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass II

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

by Bayer Healthcare Pharmaceuticals Inc.

Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass II

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

by Bayer Healthcare Pharmaceuticals Inc.

Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Drug Recall Terminated Historical recordClass II

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

by Bayer Healthcare Pharmaceuticals Inc.

Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recall initiated: October 1, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

View recall →

Data last updated: September 13, 2026 ET

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.