Recall Ledger

Carton Label: MAJOR recall (The Harvard Drug Group LLC)

DrugClass IIOngoing

Summary: The Harvard Drug Group LLC is recalling 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 4626. Reason: Subpotent Drug.

What is being recalled

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.

Why

Subpotent Drug

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide.

How to tell if yours is affected

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

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0609-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 16, 2026
ReportedJuly 1, 2026
CompanyThe Harvard Drug Group LLC
Company locationDublin, OH, United States
Initiated byVoluntary: Firm initiated
Quantity790 Cartons.

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