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The Harvard Drug Group LLC recall records

8 reported ongoing

8 records in this archive. Latest source date Jun 16, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Jun 16, 2026FDA drug enforcement

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...

Subpotent Drug

Class IIReported ongoing

Distribution: U.S. Nationwide.

Official source

Apr 9, 2026FDA drug enforcement

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianap...

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Mar 24, 2026FDA drug enforcement

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 462...

Failed Dissolution Specifications

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Feb 17, 2026FDA drug enforcement

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-...

Defective container; inadequately sealed blister packaging.

Class IIReported ongoing

Distribution: Nationwide US.

Official source

Oct 10, 2025FDA drug enforcement

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Oct 10, 2025FDA drug enforcement

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (...

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIReported ongoing

Distribution: US Nationwide.

Official source

Jun 19, 2025FDA drug enforcement

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-...

Defective container; blister packaging inadequately sealed.

Class IIReported ongoing

Distribution: Nationwide

Official source

Jun 19, 2025FDA drug enforcement

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal H...

Defective container; blister packaging inadequately sealed.

Class IIReported ongoing

Distribution: Nationwide

Official source

Reasons in these listed records

Subpotent Drug
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Failed Dissolution Specifications
Defective container; inadequately sealed blister packaging.

These examples come from this result page and are not a ranking of every recall reason.

Checking The Harvard Drug Group LLC

Is there a recall on the harvard drug group llc right now?

This archive contains 8 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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