Fluocinolone Acetonide Topical Solution — Class II drug recall D-0909-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2018-07-18, distributed nationwide. Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results f
| Recall number | D-0909-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-07-05 |
| Classified | 2018-07-06 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2019-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 27,803 bottles |
| Reason classes | potency, specification failure |
| NDC | 00591-2990, 00591-2990-60 |
| Lot numbers | 01/20, 07/19, 10/18, 11/18, 1164898, 1164904, 1164909, 1211396, 1230808, 1231127 |
Product
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Reason for recall
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
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-0909-2018. 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.