Prasugrel recalls

The FDA has published 5 recalls involving Prasugrel since 2019. The latest was reported on 9 Sep 2026. Most were for potency & assay. Mylan 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 recalls5since 2019

Last 12 months2reported

Class I00% of total

Ongoing4latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 2 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 2

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why prasugrel is recalled

Potency & Assay5100%

Companies

Mylan Pharmaceuticals360%
Golden State Medical Supply240%

By year

2026240%
2025240%
2019120%

Ongoing prasugrel recalls

4 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, 5 mg recalled by Golden State Medical SupplyPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide

All prasugrel recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, 5 mg recalled by Golden State Medical SupplyPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
6 Nov 2019Drug	CLASS II	Prasugrel Tablets 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Prasugrel?

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.