← FDA ENFORCEMENT
D-0383-2026Class II

The Harvard Drug Group LLC

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2026-03-11
Distribution
Nationwide US.
Firm state
OH
Product quantity
8892 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Defective container; inadequately sealed blister packaging.

Product description

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.

Code / lot info

Lot # N02640, Exp Date: 08/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.