Betamethasone Dipropionate Lotion USP — Class II drug recall D-0802-2021
Terminated recall by Akorn, Inc., reported 2021-09-22, distributed nationwide. Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical
| Recall number | D-0802-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-09-16 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2022-08-17 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 61748-0480-30, 61748-0480-60 |
| Expiration dates | 2022-01-31 |
Product
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Reason for recall
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
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-0802-2021. 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.