Major Pharmaceuticals Recalls Methylergonovine Maleate Tablets for Subpotency

Major Pharmaceuticals, distributed by The Harvard Drug Group LLC, has issued a voluntary recall of Methylergonovine Maleate Tablets, USP, 0.2 mg, affecting 790 cartons distributed across the United States. The recall, classified as Class II by the U.S. Food and Drug Administration (FDA), was initiated due to the product being subpotent, meaning the tablets may contain less active ingredient than required by established standards.

What Products Are Being Recalled?

The recalled product is identified by the following details:

• Product Name: Methylergonovine Maleate Tablets, USP, 0.2 mg
• Brand: Major Pharmaceuticals
• NDC Number: 0904-7282-10
• Package Size: 20 Tablets (2 x 10 blister pack)
• Lot Numbers: N02327 (expires 09/2026), N02740 (expires 12/2026), N03069 (expires 08/2027)
• Units Affected: 790 cartons
• Recall Number: D-0609-2026

The product is packaged and distributed by Major Pharmaceuticals, Indianapolis, IN 46268, and was distributed on a nationwide basis across the United States.

Why Was This Recall Issued?

The recall was initiated because the affected tablets were found to be subpotent — a term used when a drug product contains less than the labeled amount of active pharmaceutical ingredient. In this case, the tablets may deliver insufficient levels of methylergonovine maleate to patients who depend on the medication for critical postpartum care.

Methylergonovine maleate is an ergot alkaloid used primarily to prevent and treat excessive bleeding following childbirth or a miscarriage. A subpotent dose may fail to adequately control uterine contractions, potentially leading to serious or life-threatening complications in postpartum patients. The FDA classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm remains low under typical circumstances.

Who Is Affected?

This recall affects patients, healthcare providers, pharmacists, and distributors who may have received or dispensed the affected lots of Methylergonovine Maleate Tablets, USP, 0.2 mg under the Major brand label. The distribution pattern covers the entire United States, meaning any facility or individual nationwide who received the product under the identified lot numbers may be in possession of recalled tablets.

Healthcare professionals who prescribe or administer this medication to postpartum patients should verify whether they have any of the recalled lots in their inventory. Pharmacies and hospital dispensaries are particularly urged to check their stock immediately.

What Should You Do?

• Check your supply: Verify whether you have Methylergonovine Maleate Tablets, USP, 0.2 mg with lot numbers N02327, N02740, or N03069 in your possession.
• Stop dispensing: Healthcare providers and pharmacies should immediately quarantine and stop dispensing the recalled lots.
• Contact the recalling firm: Reach out to The Harvard Drug Group LLC at their registered address — 7000 Cardinal Pl, Dublin, OH 43017-1091 — for return and remedy instructions.
• Consult your healthcare provider: Patients currently using this medication should not stop taking it without consulting their physician. Speak with your doctor or pharmacist about obtaining a replacement supply from a non-recalled lot.
• Monitor for symptoms: If you are a postpartum patient using this medication and experience unusual symptoms, seek medical attention promptly.

Official Statement

The recall was voluntarily initiated by the recalling firm, The Harvard Drug Group LLC, on June 16, 2026, and classified by the FDA on June 22, 2026. The FDA has assigned Event ID 99240 to this recall action. Notification to consignees was carried out via letter. No press release was issued by the firm for this recall.

The recall remains ongoing as of the time of publication. Consumers and healthcare providers seeking further information are encouraged to visit the FDA’s official recall database or contact the recalling firm directly. The FDA continues to monitor the situation to protect public health.