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Mylan Pharmaceuticals

4 recalls on record · Last recall: Aug 26, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
0
Class II — Moderate
4
Class III — Low Risk
0

Categories

MEDICATION

Recall Timeline

Class IIFDAAug 26, 2026

Mylan Pharmaceuticals — Failed Dissolution Specifications

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00. Failed Dissolution Specifications

Class IIFDAAug 17, 2026

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

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

Class IIFDAJul 24, 2026

Mylan Pharmaceuticals — Failed Dissolution Specifications

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. Failed Dissolution Specifications

Class IIFDAJul 2, 2026

MYLAN PHARMACEUTICALS — Presence of precipitate

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label). Presence of precipitate

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