FDAFDA · Food and drugs·Recall number D-0566-2025
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
Published August 13, 2025 · Recall initiated: July 25, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- DOXEPIN HYDROCHLORIDE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Distributor
- Nationwide in the USA.
- UPC
- 0362332645312
- Lot
- Lot: 2305015142, Exp. Date: 9/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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