Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit
Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a nitrosamine impurity measured above the named interim limit, with no injury reported in the source.
Plain-English summary
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 capsules per bottle, prescription only, manufactured by Alembic Pharmaceuticals Limited of Gujarat, India for Alembic Pharmaceuticals, Inc. of Bedminster, New Jersey, is being recalled. The action covers 9,492 bottles.
The stated reason is CGMP deviations: the presence of a nitrosamine drug substance related impurity above the proposed interim limit. The FDA classified the action as Class II.
The affected lot is 2305015142, expiring 9/30/2025. Distribution was nationwide in the USA.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
- Brand
- DOXEPIN HYDROCHLORIDE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Oral capsule
- Hazard
- nitrosamine
- impurity-limit
- cgmp-deviation
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 2305015142
- Exp. Date: 9/30/2025
UPCs (1)
- 0362332645312
Distribution
Distributed nationwide across the United States.
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