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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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Drug Recall Terminated Historical recordClass II

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981

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.

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Drug Recall Terminated Historical recordClass II

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain

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.

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Drug Recall Terminated Historical recordClass II

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,

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.

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Drug Recall Terminated Historical recordClass II

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.

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.

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Drug Recall Terminated Historical recordClass II

LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,

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

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: 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

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: 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.

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Drug Recall Terminated Historical recordClass III

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications
Recall initiated: October 28, 2021
Reported by FDA: November 24, 2021
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

by Amneal Pharmaceuticals of New York, LLC

Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Recall initiated: November 4, 2021
Reported by FDA: November 24, 2021
Distribution: Product was distributed nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

by Amneal Pharmaceuticals of New York, LLC

Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Recall initiated: November 4, 2021
Reported by FDA: November 24, 2021
Distribution: Product was distributed nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90

by Teva Pharmaceuticals USA

Reason: Labelling: Incorrect Exp. Date
Recall initiated: October 27, 2021
Reported by FDA: November 24, 2021
Distribution: Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Recall initiated: October 25, 2021
Reported by FDA: November 17, 2021
Distribution: Distributed to one distributor who may have further distribute the product nationwide.

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Drug Recall Terminated Historical recordClass II

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Recall initiated: October 25, 2021
Reported by FDA: November 17, 2021
Distribution: Distributed to one distributor who may have further distribute the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05

by Golden State Medical Supply Inc.

Reason: Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Recall initiated: October 14, 2021
Reported by FDA: November 17, 2021
Distribution: Distributed to two distributors located in AZ and MO

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Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

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Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason: Lack of assurance of sterility
Recall initiated: October 12, 2021
Reported by FDA: November 17, 2021
Distribution: United States including Washington, D.C. and Puerto Rico

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.