Recalls / Class II
Class IID-0566-2025
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
- Brand name
- Doxepin Hydrochloride
- Generic name
- Doxepin Hydrochloride
- Active ingredient
- Doxepin Hydrochloride
- Route
- Oral
- NDCs
- 62332-637, 62332-638, 62332-645, 62332-639, 62332-640
- FDA application
- ANDA215076
- Affected lot / code info
- Lot: 2305015142, Exp. Date: 9/30/2025
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recalling firm
- Firm
- Alembic Pharmaceuticals Limited
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A, Panchmahal, N/A N/A, India
Distribution
- Quantity
- 9,492 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-07-25
- FDA classified
- 2025-08-01
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0566-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.