Carton Label: MAJOR recall
FDA recall D-0609-2026 · initiated Jun 16, 2026
The Harvard Drug Group LLC recalled Carton Label: MAJOR in Jun 2026 — an FDA Class II recall (D-0609-2026) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 790 Cartons.
Details
- Product
- 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.
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Jun 16, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was Carton Label: MAJOR recalled?
- The Harvard Drug Group LLC recalled Carton Label: MAJOR in Jun 2026 — an FDA Class II recall (D-0609-2026) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carton Label: MAJOR recalled?
- Per the FDA enforcement record, the reason for recall D-0609-2026 was: Subpotent Drug
- Is a recalled Carton Label: MAJOR dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Carton Label: MAJOR are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0609-2026.