[pending] DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0566-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
The recalled product
- Product
- DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
- Brand
- DOXEPIN HYDROCHLORIDE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Drugs
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27