Fluocinolone Acetonide Topical Solution — Class II drug recall D-0390-2019
Terminated recall by LUPIN SOMERSET, reported 2019-01-30, distributed nationwide. Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specific
| Recall number | D-0390-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2019-01-15 |
| Classified | 2019-01-23 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2023-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 24,180 bottles |
| Reason classes | specification failure |
| NDC | 43386-0069, 43386-0069-60 |
| Lot numbers | APR-19, FEB-20, JUL-20, JUN-19, MAR-20, MAY-20, NOV-19, OCT-19, S700214, S700447, S700787, S701057, S800107, S800266, S800524, S800791 |
Product
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Reason for recall
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
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-0390-2019. 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.