The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1282-2019·Announced 2019-05-29

Losartan Potassium Tablets Recalled Due to Impurity Presence

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs confirmed 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, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

Golden State Medical Supply Inc. is recalling 11,668 bottles of Losartan Potassium Tablets USP 25 mg (NDC 60429-316-30). The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product at levels above the interim acceptable daily intake.

The affected product was distributed in Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, and Texas. Distribution included two U.S. government accounts and one Veterans Affairs account. No foreign accounts were involved. The specific lot codes are GS017981, GS016958, and GS017341, all with an expiration date of 02/2020.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. Patients should contact their healthcare provider for alternative treatment options or further instructions.

The recalled product

Product
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
11,668

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 (3)

  • GS017981 exp 02/2020
  • GS016958 exp 02/2020
  • GS017341 exp 02/2020

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 5 recalled by Golden State Medical Supply 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 5 products in this recall →

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