The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1045-2019·Announced 2019-03-27

AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

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 rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the presence of a nitrosamine impurity in a Class II drug recall typically warrants a Severe rating due to potential long-term health risks.

Plain-English summary

AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg, 50 Tablets (5x10) Unit Dose boxes. The product is identified by NDC 50268-513-15, Lot 19454, and an expiration date of 04/30/2019.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), was identified in the product.

The affected units were distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.

The recalled product

Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
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: 19454 Exp. 04/30/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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