Doxepin recalls

The FDA has published 2 recalls involving Doxepin since 2014. The latest was reported on 13 Aug 2025. Most were for labeling errors. Alembic Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 13 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why doxepin is recalled

Labeling Errors150%
Nitrosamine Impurity150%

Companies

Alembic Pharmaceuticals150%
Aidapak Services150%

By year

2025150%
2014150%

Ongoing doxepin 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 recalls, newest first

2 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
22 Jan 2014Drug	CLASS II	Doxepin HCL Capsule, 150 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Doxepin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.