MACLEODS PHARMA USA, INC recall records

2 reported ongoing

17 records in this archive. Latest source date Feb 26, 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

FDA drug enforcement

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Bad...

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Class IIIReported terminated

Distribution: Nationwide within United States and Puerto Rico.

Official source for Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma US...
FDA drug enforcement

Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical...

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

Class IIReported terminated

Distribution: Distributed Nationwide and Puerto Rico.

Official source for Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods ...
FDA drug enforcement

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC ...

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Class IIIReported terminated

Distribution: Nationwide within the United States

Official source for Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets...
FDA drug enforcement

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08...

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Class IIIReported terminated

Distribution: Nationwide within the United States

Official source for Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blis...
FDA drug enforcement

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 0...

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Class IIIReported terminated

Distribution: Nationwide within the United States

Official source for Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Bli...

Reasons in these listed records

  • Subpotent Drug
  • Presence of foreign substance: plastic-like substance.
  • Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
  • Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

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

Checking MACLEODS PHARMA USA, INC

Is there a recall on macleods pharma usa, inc right now?

This archive contains 17 records, including 2 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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