FDA recall, , Moderate risk
Major Methylergonovine Maleate Tablets
Methylergonovine Maleate Tablets are subpotent.
Summary by Recall Canary from the FDA notice
What happened
The Harvard Drug Group LLC, based in Dublin, Ohio, 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, and Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, because the drug is subpotent. The recall began June 16, 2026, and was added to the FDA's Enforcement Report on June 22, 2026.
The product was distributed nationwide in the U.S. The recall involves 790 cartons.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Methylergonovine Maleate Tablets, USP, 0.2 mg
- NDC
- 0904-7282-10
- Lot code
- N02327
Recall details
- Company began the recall
- Sold in
U.S. Nationwide.
- Company
- The Harvard Drug Group LLCDublin, Ohio
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99240
- Recall number
- D-0609-2026
- Quantity recalled
- 790 Cartons.
All recalls from The Harvard Drug Group LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
