Nystatin and Triamcinolone Acetonide Cream — Class II drug recall D-0676-2017
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2017-04-26, distributed nationwide. Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
| Recall number | D-0676-2017 |
|---|---|
| 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 | 2017-03-28 |
| Classified | 2017-04-20 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2019-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 278,304 tubes |
| Reason classes | specification failure |
| NDC | 51672-1263, 51672-1263-01, 51672-1263-02, 51672-1263-03, 51672-1272, 51672-1272-01, 51672-1272-02, 51672-1272-03 |
| Lot numbers | B504918500, B505118501, D504519119, I416616979, I416716979 |
| Expiration dates | 2017-08-20, 2018-01-20, 2018-03-20 |
Product
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Reason for recall
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
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-0676-2017. 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.