The Recall Desk
SevereFDA (Drugs)·D-1049-2019·Announced 2019-03-27

Losartan Potassium Tablets Recalled Due to Impurity Presence

Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, due to the presence of an impurity, N-Methylnitrosobutyric acid (NMBA).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles. The product is distributed by Wal-Mart and manufactured for Camber Pharmaceuticals, Inc. The recall involves 2,851,284 bottles.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of an impurity known as N-Methylnitrosobutyric acid (NMBA). The affected lots include 180921, 180922, 180923, 180924, 181118, 181119, 181407, 181408, 181573, 181725, 181726, 181948, 181960, 182385, 182386, and 182387, with expiration dates ranging from September 2019 to March 2020.

The product was distributed to Wal-Mart distribution centers in Arkansas, California, Georgia, Indiana, and Maryland. Consumers should check their medication for the NDC 68645-578-54 and the specific lot numbers listed above. If the medication matches these details, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
Manufacturer
Legacy Pharmaceutical Packaging LLC
Category
Drug — Prescription Medication
Hazard
Affected units
2,851,284

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 (20)

  • Lots: 180921
  • exp Sep-19
  • 180922
  • exp Oct-19
  • 180923
  • 180924
  • 181118
  • exp Nov-19
  • 181119
  • 181407
  • 181408
  • exp Dec-19
  • 181573
  • 181725
  • 181726
  • exp Feb-20
  • 181948
  • exp Mar-20
  • 181960
  • 182385

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 recalled by Legacy Pharmaceutical Packaging LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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