The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1456-2019·Announced 2019-07-17

Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

Teva Pharmaceuticals is recalling Losartan Potassium 100 mg tablets because an impurity was detected in the active ingredient.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant health risks or potential for serious injury are categorized as Severe (Score 4), particularly when specific impurities like NMBA are involved.

Plain-English summary

Teva Pharmaceuticals USA is recalling Losartan Potassium 100 mg tablets (NDC 00591-3747-00) in 90-count bottles. The recall involves 2,943,000 tablets distributed nationwide through four major distributors. The specific lots affected include bulk product lots 1163892A, 1163893A, 1163894A, and 1163895A, as well as finished product lots GS017042, GS017043, GS017044, and GS017541, all with an expiration date of 01/2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity identified as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products. The FDA has classified this recall as Class II.

Consumers who have these specific lots of Losartan Potassium 100 mg tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recalled products were distributed nationwide.

The recalled product

Product
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
2,943,000

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 (9)

  • Arrow Malta (Teva) Bulk Product Lot # 1163892A
  • exp. date 01/2020 1163893A
  • exp. date 01/2020 1163894A
  • exp. date 01/2020 1163895A
  • exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042
  • exp. date 01/2020 GS017043
  • exp. date 01/2020 GS017044
  • exp. date 01/2020 GS017541
  • exp. date 01/2020

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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