FDA Drug recall D-0297-2022
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-…
- FDA Drug
- Class II
- terminated
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-… by Teligent Pharma, citing failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0297-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-23 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Reason
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Identifiers
| code_info | Lot # 16569, Exp 9/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Teligent Pharma
- Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma - Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by:…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0297-2022%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.