The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1249-2019·Announced 2019-05-08

AvKARE Recalls Losartan Potassium Tablets Due to Impurity

AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

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 recall is classified as FDA Class II, and the presence of a nitrosamine impurity (NMBA) above acceptable levels constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/health risk reports.

Plain-English summary

AvKARE Inc. is recalling Losartan Potassium Tablets USP 50 mg, 50 tablets (5x10) Unit Dose, NDC 50268-517-15. The recall involves 1,438 cartons containing 71,900 tablets. The affected lot number is 20121 with an expiration date of 6/30/2019. The product was distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels exceeding the interim acceptable daily intake limit of 0.96 parts per million.

Consumers and healthcare providers should stop using the affected tablets and contact their pharmacist or healthcare provider for guidance on alternative treatment options.

The recalled product

Product
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard

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 (1)

  • Lot: 20121 Exp. 6/30/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE Inc. 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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