Mylan Pharmaceuticals Inc — 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.

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Provider: FDA — drug enforcement reference
Source observed: 9/9/2026, 12:00:00 AM UTC
Source updated: 9/9/2026, 12:00:00 AM UTC
Location: Morgantown, WV, US
hazard: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: 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.
distribution: Nationwide within the U.S
manufacturer: Mylan Pharmaceuticals Inc
recall number: D-0839-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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