FDAHealthJuly 25, 2025
Alembic Pharmaceuticals Limited — Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for
⚠️ CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 25, 2025
Nationwide in the USA.
What's affected?
- 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
- UPC
- 0362332645312
- Lot code
- 2305015142
Additional details
Lot: 2305015142, Exp. Date: 9/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9,492 bottles.
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