Class II · Moderate risk
Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Is Prasugrel recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Prasugrel (5 total). Check the affected lots below.
Most common reason: Dissolution failure (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Prasugrel. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Prasugrel recalls in 2026
2 initiated in 2026, 5 in total — newest first
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications - low dissolution results
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
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