Warfarin recalls

The FDA has published 7 recalls involving Warfarin since 2013. The latest was reported on 3 Jan 2024. Most were for manufacturing (cgmp) deviations. Aidapak Services 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 recalls7since 2013

Last 12 months0reported

Class I114% of total

Ongoing0latest 3 Jan 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 1 14%Class II 5 71%Class III 1 14%

Why warfarin is recalled

Companies

By year

2024229%
2023114%
2014343%
2013114%

All warfarin recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Warfarin Sodium Tablets, USP, 5 mg recalled by Cardinal HealthcareWarfarin Sodium	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Jan 2024Drug	CLASS II	Warfarin Sodium Tablets, USP, 5 mg recalled by Cardinal HealthcareWarfarin Sodium	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
1 Mar 2023Drug	CLASS II	Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Potency & Assay	Nationwide
24 Sep 2014Drug	CLASS III	Warfarin Sodium Tablets, USP Crystalline, 2 mg recalledWarfarin Sodium	Taro Pharmaceuticals U.S.A	Other	7 states
22 Jan 2014Drug	CLASS II	Warfarin Sodium Tablet, 5 mg (1/2 of 1 mg) recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Warfarin Sodium Tablet, 5 mg (1/2 of 1 mg) recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
14 Aug 2013Drug	CLASS I	Warfarin Sodium Tablets, USP 2 mg recalled by Zydus Pharmaceuticals USA	Zydus Pharmaceuticals USA	Other	Nationwide

Should you stop taking Warfarin?

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.