TopCare Health — Class II drug recall D-0158-2021
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2020-12-23, distributed nationwide. Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the
| Recall number | D-0158-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00036800495692 |
| NDC | 36800-0495, 36800-0495-69 |
| Lot numbers | 200, 252, D867331277 |
| Expiration dates | 2021-03-20 |
Product
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
Reason for recall
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0158-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.