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Browse Drug Recalls

41 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 41 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 41 FDA drug recalls.

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DateProductReasonClassFirm
Jan 27, 2026 Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharma... Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] resul... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Aug 7, 2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... Class III Taro Pharmaceuticals U.S.A., Inc.
Nov 6, 2023 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... Class III Taro Pharmaceuticals Inc.
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Dec 15, 2021 Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria Class I Taro Pharmaceuticals U.S.A., Inc.
Mar 15, 2021 Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Gr... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Jan 8, 2021 Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac... CGMP deviations. Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (2... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), D... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal,... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Jul 20, 2020 Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 7, 2020 Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... Class I Taro Pharmaceuticals U.S.A., Inc.
Dec 20, 2019 Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Class I Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Man... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manu... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Dec 21, 2017 Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Phar... Failed Content Uniformity Specifications Class III Taro Pharmaceuticals U.S.A., Inc.
Sep 20, 2017 Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... Cross contamination with other products: traces of Dapsone were found in the finished product. Class III Taro Pharmaceuticals U.S.A., Inc.
Mar 28, 2017 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Class II Taro Pharmaceuticals U.S.A., Inc.
Mar 17, 2017 Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx on... Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be cont... Class III Taro Pharmaceuticals U.S.A., Inc.
Sep 13, 2016 Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... Class II Taro Pharmaceuticals, Inc.
Sep 13, 2016 Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... Class II Taro Pharmaceuticals, Inc.
May 26, 2016 Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Ka... Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc py... Class III Taro Pharmaceuticals U.S.A., Inc.
Mar 31, 2016 ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professio... Subpotent Drug Class III Taro Pharmaceuticals U.S.A., Inc.
Dec 30, 2014 Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistami... Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 21, 2014 Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufact... Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was err... Class III Taro Pharmaceuticals U.S.A., Inc.
Aug 25, 2014 Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, ... Failed Content Uniformity Specifications. Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 16, 2013 Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... Subpotent. drug Class III Taro Pharmaceuticals U.S.A., Inc.
Nov 21, 2012 Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmac... Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and descripti... Class II Taro Pharmaceuticals U.S.A., Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.