METHYLERGONOVINE MALEATE Tablets 0.2 mg Drug Recall
The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a subpotent drug product with no reported illnesses or injuries documented in the source text. Per the rubric, Class II recalls without hospitalization reports or reported illness typically fall into the Moderate range.
Plain-English summary
The Harvard Drug Group LLC is voluntarily recalling METHYLERGONOVINE MALEATE Tablets, USP, 0.2 mg (brand name: MAJOR) because the tablets may be subpotent. The defect was identified by the firm and the recall was initiated on June 16, 2026.
The affected product was packaged and distributed by MAJOR PHARMACEUTICALS in Indianapolis, Indiana. The recalled cartons contain 20 tablets (2 × 10 blister packs) with NDC 0904-7282-10. Three lot numbers are involved: N02327 (expires 09/2026), N02740 (expires 12/2026), and N03069 (expires 08/2027). Approximately 790 cartons were distributed to U.S. nationwide locations.
Patients taking this medication should consult their healthcare provider immediately about their treatment. Healthcare providers and patients with affected product should contact The Harvard Drug Group LLC. The product should not be used.
This is a Class II recall and an ongoing investigation by the FDA. Consumers with questions should contact their pharmacist or physician.
The recalled product
- Product
- METHYLERGONOVINE MALEATE (METHYLERGONOVINE MALEATE)
- Brand
- METHYLERGONOVINE MALEATE
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription Tablet
- Hazard
- Affected units
- 790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots: N02327
- expires: 09/2026
- N02740
- expires: 12/2026
- N03069
- expires: 08/2027.
Distribution
Distributed nationwide across the United States.
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