Fluocinolone Acetonide Topical Solution — Class II drug recall D-0092-2019
Terminated recall by LUPIN SOMERSET, reported 2018-10-31, distributed nationwide. Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed
| Recall number | D-0092-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2018-10-05 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2022-11-08 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 43386-0069, 43386-0069-60 |
| Lot numbers | M16666 |
| Expiration dates | 2018-12 |
Product
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
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-0092-2019. 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.