Propafenone recalls

The FDA has published 5 recalls involving Propafenone since 2017. The latest was reported on 16 Apr 2025. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., U 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 recalls5since 2017

Last 12 months0reported

Class I00% of total

Ongoing4latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 4Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why propafenone is recalled

Manufacturing (CGMP) Deviations480%
Potency & Assay120%

Companies

By year

2025480%
2017120%

Ongoing propafenone recalls

4 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules 225mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules, USP 325mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules USP, 225mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules 325mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide

All propafenone recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules 225mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules, USP 325mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules USP, 225mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules 325mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
13 Sep 2017Drug	CLASS III	Propafenone Hydrochloride tablets, 150 mg recalled	Mckesson Packaging Services	Potency & Assay	5 states

Should you stop taking Propafenone?

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.