FDA Drug recall D-0566-2025
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujar…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujar… by Alembic Pharmaceuticals, citing CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0566-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-25 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
Product
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Identifiers
| ndc | 62332-637-31 |
|---|---|
| ndc | 62332-637-91 |
| ndc | 62332-638-31 |
| ndc | 62332-638-91 |
| ndc | 62332-645-31 |
| ndc | 62332-645-91 |
| ndc | 62332-639-31 |
| ndc | 62332-639-91 |
| ndc | 62332-640-31 |
| ndc | 62332-640-91 |
| ndc | 2305015142 |
| code_info | Lot: 2305015142, Exp. Date: 9/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0566-2025%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.