FDAFDA recall D-0609-2026 · Jul 1, 2026
The Harvard Drug Group LLC: Carton Label: MAJOR recall
Recall found
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.
Reason for recall
Subpotent Drug
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.
- Quantity
- 790 Cartons.
- Distribution
- U.S. Nationwide.
- Recalling firm
- The Harvard Drug Group LLC, Dublin, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-16
Source: openFDA enforcement record D-0609-2026 · search recall number D-0609-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.