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Lower risk Drug recall · FDA · Published June 16, 2026

Harvard Drug Group Recalls Methylergonovine Tablets Due to Subpotent Drug Risk

Harvard Drug Group recalls methylergonovine maleate tablets (0.2 mg) with subpotent drug risk. Affected lots expire 09/2026 to 08/2027. Consumers should contact the manufacturer for details.

🇺🇸 FDA recall #D-0609-2026DrugThe Harvard Drug Group ›
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Recalling firmThe Harvard Drug Group LLC7000 Cardinal Pl · Dublin, OH 43017-1091
✎ GovInfoNow plain-language explainer

Harvard Drug Group is recalling methylergonovine maleate tablets (0.2 mg) because they may be subpotent. This means the medication might not work as intended, which could lead to ineffective treatment for conditions like postpartum hemorrhage. Read more at govinfonow.com/recall/31196-harvard-drug-group-recalls-methylergonovine-tablets-due-to-subpotent-drug.

Source Summary by GovInfoNow · govinfonow.com/recall/31196-harvard-drug-group-recalls-methylergonovine-tablets-due-to-subpotent-drug · Updated August 10, 2026 · FDA enforcement record: FDA #D-0609-2026

Cite this page

“Harvard Drug Group Recalls Methylergonovine Tablets Due to Subpotent Drug Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31196-harvard-drug-group-recalls-methylergonovine-tablets-due-to-subpotent-drug. Based on FDA recall #D-0609-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0609-2026%22&limit=1).

The Food and Drug Administration announced on June 16, 2026, that The Harvard Drug Group LLC is recalling Methylergonovine Maleate Tablets due to subpotent drug risks. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: The Harvard Drug Group
  • Product: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10)
  • NDC: 0904-7282-10
  • Lots: N02327 (expires 09/2026), N02740 (expires 12/2026), N03069 (expires 08/2027)
  • Quantity: 790 Cartons
  • Distribution: U.S. Nationwide

The hazard

The recall is classified as Class II because the Methylergonovine Maleate Tablets are subpotent, meaning they may not contain the labeled amount of active ingredient. The FDA stated that this defect could result in inadequate treatment for the condition for which the drug is prescribed.

Context

GovInfoNow's records show The Harvard Drug Group, LLC has issued seven other recalls since December 31, 2014. Recent brand recalls include a March 24, 2026, recall of Memantine Capsules for failed dissolution specifications and an April 9, 2026, recall of Omega-3 Capsules due to failed capsule specifications. Other recent recalls of similar products include the May 29, 2026, Gasco Isopropyl Alcohol 70% recall for subpotent drug risk and the July 13, 2026, Major Pharmaceuticals Levothyroxine Tablets recall for subpotent drug risk.

How to tell if you have this one

Check the blister label for the product name 'Methylergonovine Maleate Tablets, 0.2 mg, USP'. Look for lot numbers N02327 (expires 09/2026), N02740 (expires 12/2026), or N03069 (expires 08/2027).

  • Brand
    The Harvard Drug Group
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number on the blister label to confirm if your tablets are in the recalled lots.

  2. Contact Manufacturer

    Reach out to Harvard Drug Group for specific instructions on what to do with the recalled tablets.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: Jun 16, 202612. FDA classified it Class II: Jun 22, 202623. Published in FDA’s Enforcement Report: Jul 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0609-2026 (June 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0609-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA