← FDA ENFORCEMENT
D-0609-2026Class II

The Harvard Drug Group LLC

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2026-07-01
Distribution
U.S. Nationwide.
Firm state
OH
Product quantity
790 Cartons.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug

Product description

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.

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

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.