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Doxepin Hydrochloride recalls

Doxepin Hydrochloride products have been recalled 1 time, most recently on 13 Aug 2025. The recalling company is usually Alembic Pharmaceuticals. The most common reason is nitrosamine impurity.

Total recalls1since 2025

Last 12 months0reported

Class I00% of total

Ongoing1latest 13 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why doxepin hydrochloride is recalled

Nitrosamine Impurity1100%

Companies

Alembic Pharmaceuticals1100%

By year

20251100%

Ongoing doxepin hydrochloride recalls

1 active

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride	Alembic Pharmaceuticals	Nitrosamine Impurity	Nationwide

All doxepin hydrochloride recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride	Alembic Pharmaceuticals	Nitrosamine Impurity	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.