The Recall Desk
SevereFDA (Drugs)·D-1050-2019·Announced 2019-03-27

Losartan Potassium Tablets Recalled Due to Impurity Detection

Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported, the presence of a nitrosamine impurity in a prescription drug is a significant health risk warranting a Severe rating under the 'significant injury' or high-risk pathogen/impurity criteria.

Plain-English summary

Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles. The product is distributed by Wal-Mart and manufactured for Camber Pharmaceuticals, Inc. The recall involves 2,497,856 bottles.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the impurity N-Methylnitrosobutyric acid (NMBA). The affected lots were distributed to Wal-Mart distribution centers in Arkansas, California, Georgia, Indiana, and Maryland.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The specific lot codes and expiration dates are listed in the official recall notice.

The recalled product

Product
Losartan Potassium Tablets, USP, 100 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 68645-579-54
Manufacturer
Legacy Pharmaceutical Packaging LLC
Category
Drug — Prescription Medication
Hazard
Affected units
2,497,856

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)

  • 180886
  • Nov-19
  • 180887
  • 180888
  • 180905
  • Dec-19
  • 181123
  • Sep-2019
  • 181124
  • Oct-2019
  • 181125
  • Aug-19
  • 181351
  • 181352
  • 181551
  • 181628
  • 181629
  • 181727
  • 181728
  • Jun-20

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 →

Related recalls

Same manufacturer · Legacy Pharmaceutical Packaging LLC

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Same hazard · impurity

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