Taro Recalls Fluorouracil Topical Cream Due to Stability Issues
Taro Pharmaceuticals is recalling Fluorouracil Topical Cream 5% because out-of-specification results were found in retain samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to product stability rather than a high-risk pathogen or structural defect.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling Fluorouracil Topical Cream USP, 5%, 40 g Tube. The recall involves 39,982 tubes distributed nationwide and in Puerto Rico.
The recall was initiated because out-of-specification (OOS) results were observed for assay and description in retain samples, indicating the product lacks stability. The affected lots have expiration dates ranging from March 2013 to January 2014.
Consumers and healthcare providers should stop using the affected product and contact Taro Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- FLUOROURACIL (FLUOROURACIL)
- Brand
- FLUOROURACIL
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Hazard
- Affected units
- 39,982
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #s: 118903
- Exp. March 2013
- 119477
- 119483
- 119743
- Exp. May 2013
- 119748
- June 2013
- 110440
- Exp. September 2013
- 110599
- 110602
- 110606
- 110607
- 110949
- 110951
- 110953
- 110954
- 110956
- 110958
Distribution
Related recalls
Same brand · FLUOROURACIL
- CriticalFresenius Kabi Recalls Fluorouracil Injection Due to Glass Particulates
FDA (Drugs) · 2019-07-24
Same manufacturer · Taro Pharmaceuticals U.S.A., Inc.
See all →- ModerateHydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures
FDA (Drugs) · 2024-08-21
- ModerateClotrimazole and Betamethasone Topical Cream Recalled for Failed Potency Specifications
FDA (Drugs) · 2022-04-06
- SevereClobetasol Propionate Ointment Recalled for Microbial Contamination
FDA (Drugs) · 2022-01-19
- HighTaro Recalls Nortriptyline Hydrochloride Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2021-02-10
- ModerateTaro Recalls Rite Aid Clotrimazole Cream Due to Impurity
FDA (Drugs) · 2020-12-23
Same hazard · product stability
See all →- ModerateMoxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation
FDA (Drugs) · 2023-01-18
- ModerateFDA Recalls MIOSTAT Carbachol Solution Nationwide for Temperature Abuse
FDA (Drugs) · 2022-06-15
- HighDrug recall: Thrombin JMI injection kits due to manufacturing temperature deviation
FDA (Drugs) · 2022-06-15
- SevereSandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion
FDA (Drugs) · 2021-12-08
- ModerateLoratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits
FDA (Drugs) · 2021-11-03