The Recall Desk
SevereFDA (Drugs)·D-1455-2019·Announced 2019-07-17

Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

Teva Pharmaceuticals USA is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

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' rating under the provided rubric, particularly given the detection of a nitrosamine impurity in a pharmaceutical product.

Plain-English summary

Teva Pharmaceuticals USA is recalling Losartan Potassium 50 mg tablets, available in 90-count and 1,000-count bottles, due to the detection of an impurity in the active pharmaceutical ingredient (API). The specific impurity identified is N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The recall involves approximately 2,924,000 tablets distributed nationwide through four major distributors.

The affected products are identified by specific lot numbers and expiration dates. Bulk product lots include 1169752A and 1169753A, both with an expiration date of 01/2020. Finished product lots include GS017387, GS017651, and GS017479, all with an expiration date of 01/2020. The NDC number for the recalled product is 00591-3746-00.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the distributor or pharmacy for proper handling. This recall is classified as Class II by the FDA, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.

The recalled product

Product
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
2,924,000

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 (6)

  • Arrow Malta (Teva) Bulk Product Lot # 1169752A
  • exp. date 01/2020
  • 1000 tablets/bottle 1169753A
  • 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387
  • exp. date 01/2020 GS017651
  • exp. date 01/2020 GS017479

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Teva Pharmaceuticals USA 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 2 products in this recall →

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