Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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
Lot numbers, UPCs & expiration codes
Lot: 2305015142, Exp. Date: 9/30/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0566-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 25, 2025
- FDA report date
- Aug 13, 2025
- Quantity
- 9,492 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0566-2025, exactly as published.
Show all FDA fields
- City
- Panchmahal
- Status
- Ongoing
- Country
- India
- Event ID
- 97323
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol
- Code information
- Lot: 2305015142, Exp. Date: 9/30/2025
- Report date
- Aug 13, 2025
- Product type
- Drugs
- Recall number
- D-0566-2025
- Classification
- Class II
- Recalling firm
- Alembic Pharmaceuticals Limited
- Product quantity
- 9,492 bottles
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jul 25, 2025
- Center classification date
- Aug 1, 2025