Fluocinonide Ointment USP 0 — Class III drug recall D-0064-2021
Terminated recall by Teligent Pharma, Inc., reported 2020-11-11, distributed nationwide. Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
| Recall number | D-0064-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2020-09-28 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2022-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 36,790 tubes |
| Reason classes | specification failure |
| NDC | 52565-0040-15, 52565-0040-30, 52565-0040-60 |
| Expiration dates | 2020-10, 2021-08, 2021-12, 2022-01, 2022-02, 2022-03, 2022-04, 2022-07 |
Product
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
Reason for recall
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
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-0064-2021. 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.