CLASS II ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
Carton Label: Major, Methylergonovine Maleate Tablets recalled
The Harvard Drug Group is recalling Carton Label: Major, Methylergonovine Maleate Tablets, USP, 0.2 mg (2 x, distributed nationwide in the US. The recall was initiated on 16 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0609-2026
- FDA event ID
- 99240
- Recalling firm
- The Harvard Drug Group, Dublin, OH
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jun 2026
- FDA classified
- 22 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Jun 2026 | Recall initiated by company | |
| 22 Jun 2026 | Classified by FDA | +6 days |
| 1 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Methylergonovine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylergonovine Maleate Tablet, 0.2 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |