Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only,
FDA confirms N-nitrosodiethylamine (NDEA) impurity in Golden State Medical Supply's 300mg IRBESARTAN tablets. Rx-only bottles with specific NDC numbers and lot dates are affected. Consumers should contact the manufacturer for details.
Recall notice
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Contact the company & request your remedy
What happened, in plain English
Golden State Medical Supply has recalled two types of 300mg IRBESARTAN tablets due to FDA-confirmed presence of a harmful impurity (NDEA) in the product. This impurity could pose a risk to health, especially for people taking the medication as prescribed. Read more at govinfonow.com/recall/39448-golden-state-medical-supply-recalls-300mg-irbesartan-tablets-with-ndea.
Source Summary by GovInfoNow · govinfonow.com/recall/39448-golden-state-medical-supply-recalls-300mg-irbesartan-tablets-with-ndea · Updated October 5, 2026 · FDA enforcement record: FDA #D-0265-2019
Cite this page
“Golden State Medical Supply recalls 300mg IRBESARTAN tablets with NDEA impurity.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39448-golden-state-medical-supply-recalls-300mg-irbesartan-tablets-with-ndea. Based on FDA recall #D-0265-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2019%22&limit=1).
Why it’s dangerous
The FDA found an impurity called N-nitrosodiethylamine (NDEA) in the medication. This chemical is known to be harmful and could potentially cause health issues when taken regularly.
Who’s affected
People who have been prescribed these specific IRBESARTAN tablets by a doctor are affected. Those with the recalled product (NDC 60429-642-30 or 60429-642-90) are most at risk.
How to tell if you have this one
Check your prescription bottle for the label 'IRBESARTAN Tablets, USP 300 mg' with either NDC 60429-642-30 (30-count) or NDC 60429-642-90 (90-count). The product is only available by prescription.
- Brand
Golden State Medical Supply- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed throughout the United States.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0263-2019 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.; Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19 | 2,439 bottles |
| D-0264-2019 | 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.; 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 | 15,917 bottles |
| D-0265-2019 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.; Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20 | 12,502 bottles |
What to do — step by step
Contact Manufacturer
Reach out to Golden State Medical Supply for specific instructions on how to return or dispose of the recalled tablets.
Questions people ask
Is this product safe to take?
No, the FDA confirmed the presence of a harmful impurity (NDEA) in these tablets, so they should not be used.
What should I do if I have this product?
Contact Golden State Medical Supply directly for instructions on returning or disposing of the recalled tablets.
Are there any specific lot numbers I should check?
Yes, the recalled products have specific lot numbers and expiration dates listed in the recall notice.
Contact Golden State Medical Supply
We’ve drafted a message you can send Golden State Medical Supply to request your refund or repair — edit it as you like.
Subject: Recall D-0265-2019 — Golden State Medical Supply Golden State Medical Supply Hello, I own a Golden State Medical Supply that is covered by recall D-0265-2019 from Golden State Medical Supply. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0265-2019 (November 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0265-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.