FDA Drug recall D-0338-2021
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc
- FDA Drug
- Class III
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class III recall of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc by Teligent Pharma, citing failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0338-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-02 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Reason
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Identifiers
| code_info | Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022 |
|---|
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-0338-2021%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.