FDA Issues a Class II Recall of Prasugrel Tablets

Mylan Pharmaceuticals Inc. has issued a voluntary Class II recall of prasugrel tablets, USP, 5 mg after routine testing revealed low dissolution results, indicating that affected tablets may not dissolve properly in the body. The recall applies to lot numbers 3211073, 3211074, and 3211075, which have an expiration date of April 30, 2026. The product was distributed in 30-count bottles under NDC 0378-5185-93 and was shipped nationwide within the US.

The company began notifying consignees via letter on February 25, 2025, with the US Food and Drug Administration (FDA) officially classifying the recall on March 17, 2025. Dissolution failures may lead to reduced drug availability in the bloodstream, potentially diminishing the drug’s therapeutic effect. No press release has been issued for this recall, and the total quantity of affected product has not been publicly disclosed.

Prasugrel is an FDA-approved antiplatelet agent indicated to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI). It works by inhibiting platelet aggregation, helping prevent blood clots that can lead to heart attack or stroke. Pharmacists are advised to check their inventories and quarantine any affected lots to prevent compromised patient outcomes.