Doxepin Hydrochloride Capsules — Class II drug recall D-0566-2025
Ongoing recall by Alembic Pharmaceuticals Limited, reported 2025-08-13, distributed nationwide. CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
| Recall number | D-0566-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alembic Pharmaceuticals Limited, Panchmahal, N/A, India |
| Recall initiated | 2025-07-25 |
| Classified | 2025-08-01 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 9,492 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 62332-0637, 62332-0637-31, 62332-0637-91, 62332-0638, 62332-0638-31, 62332-0638-91, 62332-0639, 62332-0639-31, 62332-0639-91, 62332-0640, 62332-0640-31, 62332-0640-91, 62332-0645, 62332-0645-31, 62332-0645-91 |
| Lot numbers | 2305015142 |
| Expiration dates | 2025-09-30 |
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 for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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-0566-2025. 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.