CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report

Losartan Potassium Tablets, USP, 25 mg recalled

Golden State Medical Supply is recalling Losartan Potassium Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 3 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: GS018406, Exp. Date 6/30/2020; GS018858, Exp. Date 7/31/2020; GS019108, Exp. Date 7/31/2020; GS018521, Exp. Date 7/31/2020; GS018605, Exp. Date 7/31/2020; GS018911, Exp. Date 7/31/2020

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1238-2020
FDA event ID: 85401
Recalling firm: Golden State Medical Supply, Camarillo, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2020
FDA classified: 13 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

3 Apr 2020	Recall initiated by company
13 Apr 2020	Classified by FDA	+10 days
22 Apr 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

Which lots are affected?

Lot Code: GS018406, Exp. Date 6/30/2020; GS018858, Exp. Date 7/31/2020; GS019108, Exp. Date 7/31/2020; GS018521, Exp. Date 7/31/2020; GS018605, Exp. Date 7/31/2020; GS018911, Exp. Date 7/31/2020

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Golden State Medical Supply

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27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
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Other Losartan recalls

All 98

Reported	Class	Recall	Company	Reason	Where
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
12 Jul 2023Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Foreign Material	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide