Notice names this product. Mylan Pharmaceuticals’s Prasugrel Tablets is named in FDA Class II recall D-0839-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria Identifying details: Lot #: 3225272, Exp. September 30, 2026. Units affected: 47,662 bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Company / brand: Mylan Pharmaceuticals recalls
Affected product: Prasugrel Tablets recall status
Official ID D-0839-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.