Betamethasone Dipropionate Ointment USP — Class III drug recall D-0339-2021
Terminated recall by Teligent Pharma, Inc., reported 2021-05-05, distributed nationwide. Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
| Recall number | D-0339-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2021-02-02 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2024-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 79,416 tubes |
| Reason classes | specification failure |
| NDC | 52565-0019-51 |
| Lot numbers | 14297, 15757, 15840, 15970, 15993 |
| Expiration dates | 2021-09, 2022-06, 2022-07, 2022-09 |
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
Reason for recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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-0339-2021. 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.