Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class ILotrimin 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.
Chemical Contamination: presence of benzene
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class ILOTRIMIN 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
Chemical Contamination: presence of benzene
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class ILOTRIMIN 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
Chemical Contamination: presence of benzene
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class ILOTRIMIN 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
Chemical Contamination: presence of benzene
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IITinactin (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.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IITinactin (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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IITinactin (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 Healthcar
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IITinactin (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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILotrimin 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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILOTRIMIN 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,
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILOTRIMIN 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.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILOTRIMIN 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, ,
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILOTRIMIN 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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugBayer Healthcare Pharmaceuticals Inc.Class IILOTRIMIN 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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- 2021-11-24FDA-DrugTeva Pharmaceuticals USAClass IIIClonidine 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
Failed Impurities/Degradation Specifications
- 2021-11-24FDA-DrugAmneal Pharmaceuticals of New York, LLCClass IIFlocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
- 2021-11-24FDA-DrugAmneal Pharmaceuticals of New York, LLCClass IIFlocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
- 2021-11-24FDA-DrugTeva Pharmaceuticals USAClass IICartia 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
Labelling: Incorrect Exp. Date
- 2021-11-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IITadalafil 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
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- 2021-11-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IITadalafil 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
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- 2021-11-17FDA-DrugAscend Laboratories LLCClass IICefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Failed Impurities/Degradation Specifications
- 2021-11-17FDA-DrugGolden State Medical Supply Inc.Class IIEzetimibe 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
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-17FDA-DrugGolden State Medical Supply Inc.Class IIEzetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-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
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-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
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-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
Lack of assurance of sterility
- 2021-11-17FDA-DrugVita Pharmacy, LLC dba Talon Compounding PharmacyClass IITRI-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
Lack of assurance of sterility
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief