Diflorasone Diacetate Ointment USP — Class II drug recall D-0636-2021
Terminated recall by Teligent Pharma, Inc., reported 2021-06-30, distributed nationwide. Presence of Foreign Substance: Foreign particles observed during routine stability testing.
| Recall number | D-0636-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2021-05-14 |
| Classified | 2021-06-23 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2022-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 6,240 tubes |
| Reason classes | specification failure |
| NDC | 52565-0063-15, 52565-0063-30 |
| Lot numbers | 16264 |
| Expiration dates | 2022-11-20 |
Product
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
Reason for recall
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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-0636-2021. 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.