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Recall Observatory FDA recall evidence

Drug product

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

D-0383-2026

February 17, 2026

Class II

Product summary

Firm
The Harvard Drug Group LLC
Event
Event 98456
Status
Ongoing
Classification
Class II
Quantity
8892 cartons
Official record key
drug-enforcement:D-0383-2026

Official wording

Reason: Defective container; inadequately sealed blister packaging.

Code information: Lot # N02640, Exp Date: 08/2027

Distribution pattern: Nationwide US.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container; inadequately sealed blister packaging.