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Recall Observatory FDA recall evidence

Drug product

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.

D-0609-2026

June 16, 2026

Class II

Product summary

Firm
The Harvard Drug Group LLC
Event
Event 99240
Status
Ongoing
Classification
Class II
Quantity
790 Cartons.
Official record key
drug-enforcement:D-0609-2026

Official wording

Reason: Subpotent Drug

Code information: Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent

Field note

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