FDA Drug recall D-0802-2021
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…
- FDA Drug
- Class II
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of 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… by Akorn, citing failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0802-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-13 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Identifiers
| code_info | Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0802-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.