CLASS II Drug recall · Reported 28 Nov 2018 · FDA Enforcement Report
Irbesartan Tablets, USP 150 mg (a) bottle recalled
Golden State Medical Supply is recalling Irbesartan Tablets, USP 150 mg (a) bottle (, distributed nationwide in the US. The recall was initiated on 2 Nov 2018 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-0264-2019
- FDA event ID
- 81500
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2018
- FDA classified
- 20 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 2 Nov 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +18 days |
| 28 Nov 2018 | 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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
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
IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Which lots are affected?
Lot Numbers: 30-count bottles: GS019526; Exp. 11/19 GS020252; Exp. 11/19 GS020958; Exp. 11/19 Lot Numbers: 90-count bottles B161003; Exp. 09/19 B161004; Exp. 09/19 B161006; Exp. 09/19 B161007; Exp. 09/19 B161008; Exp. 11/19 B161009; Exp. 11/19 B161010; Exp. 11/19 C161001; Exp. 02/20 C161003; Exp. 05/20
Where was it sold?
Product was distributed throughout the United States.
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
2 other products · FDA event 81500This product is part of a recall event; the main page for the event is Irbesartan Tablets, USP 300 mg (a) bottle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Irbesartan Tablets, USP 300 mg (a) bottle recalled | Golden State Medical Supply | Nitrosamine Impurity | Nationwide | |
| CLASS II | Irbesartan Tablets, USP 75 mg recalled by Golden State Medical Supply | Golden State Medical Supply | Nitrosamine Impurity | Nationwide |
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|---|---|---|---|---|---|
| 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 |
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Other Irbesartan recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) recalled | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan Tablets USP, 75 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |