D-0566-2025 Class II Ongoing
FDA drug recall D-0566-2025 was initiated by Alembic Pharmaceuticals Limited on Jul 25, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. The recall status is ongoing. Affected quantity: 9,492 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 13, 2025
- Initiation Date
- Jul 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,492 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 2305015142, Exp. Date: 9/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0566-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026