Browse Drug Recalls
18 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18 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 18 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 |
| Dec 30, 2025 | Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Dec 9, 2025 | Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., O... | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint | Class II | SUN PHARMA /TARO |
| 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. |
| 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. |
| Jul 24, 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Golden State Medical Supply 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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.