The Recall Desk
SevereFDA (Drugs)·D-1284-2019·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 testing found an impurity above acceptable levels.

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, and the presence of a nitrosamine impurity (NMBA) above acceptable levels represents a significant health risk, aligning with the 'Severe' criteria for significant injury or high-risk contamination.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets USP 25 mg, 1000 count bottles (NDC 60429-316-10). The recall involves 11,286 HDPE bottles distributed to accounts in Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, and Texas, including two U.S. government and one Veterans Affairs account.

The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product. The levels of this impurity were found to be above the interim acceptable daily intake level at the manufacturer.

Patients and healthcare providers should stop using the affected bottles and contact their healthcare provider for a replacement prescription. The specific lot codes associated with this recall are GS015204, GS018318, GS014817, GS017342, and GS017808, with expiration dates ranging from June 2019 to February 2020.

The recalled product

Product
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
11,286

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 (5)

  • GS015204 exp 06/ 2019
  • GS018318 exp 02/2020
  • GS014817 exp 06/2019
  • GS017342 exp 02/2020
  • GS017808 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 →

Related recalls

Same manufacturer · Golden State Medical Supply Inc.

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Same hazard · impurity

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