Fluorouracil Topical Cream USP — Class II drug recall D-086-2013
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2012-12-12, distributed nationwide. Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain
| Recall number | D-086-2013 |
|---|---|
| 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 | 2012-11-21 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 39,982 tubes |
| Reason classes | potency, specification failure |
| NDC | 51672-4118, 51672-4118-02, 51672-4118-05, 51672-4118-06 |
| Lot numbers | 110440, 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, 110962, 110963, 110965, 111659, 111844, 111845, 111846, 112227, 112228, 118903, 119477, 119483, 119743, 119748 |
| Expiration dates | 2013-03-20, 2013-05-20, 2013-09-20, 2013-10-20, 2013-11-20, 2013-12-20, 2014-01-20 |
Product
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Reason for recall
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
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-086-2013. 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.