CLASS II Drug recall · Reported 17 Jul 2019 · FDA Enforcement Report
Losartan Potassium recalled by Golden State Medical Supply
Golden State Medical Supply is recalling Losartan Potassium, distributed nationwide in the US. The recall was initiated on 14 Jun 2019 and the FDA has classified it as Class II.
Check your package
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-1464-2019
- FDA event ID
- 83161
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2019
- FDA classified
- 9 Jul 2019
- Reported
- 17 Jul 2019
- Type
- Voluntary: Firm initiated
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 14 Jun 2019 | Recall initiated by company | |
| 9 Jul 2019 | Classified by FDA | +25 days |
| 17 Jul 2019 | Published in enforcement report | +8 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-aminobutyric acid (NMBA) detected in the active pharmaceutical 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, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
Where it was distributed
US Nationwide One (1) US government account. No foreign accounts.
Questions about this recall
Why was it recalled?
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Which lots are affected?
Lot #: GS017387, Expiration 01/2020
Where was it sold?
US Nationwide One (1) US government account. No foreign accounts.
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.
Other products in this recall event
3 other products · FDA event 83161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Losartan Potassium recalled by Golden State Medical Supply | Golden State Medical Supply | Nitrosamine Impurity | Nationwide | |
| CLASS II | Losartan Potassium recalled by Golden State Medical Supply | Golden State Medical Supply | Nitrosamine Impurity | Nationwide | |
| CLASS II | Losartan Potassium recalled by Golden State Medical Supply | Golden State Medical Supply | Nitrosamine Impurity | Nationwide |
More recalls from Golden State Medical Supply
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |