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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Paroxetine Tablets Recalled for Impurity and Degradation Issues

Agency Publication Date: November 30, 2023
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Summary

Golden State Medical Supply Inc. is recalling 10,069 bottles of Paroxetine tablets (generic Paxil) in 10 mg, 20 mg, and 40 mg strengths. The medication was found to contain levels of a chemical impurity called Amadori Glucose adduct that exceed safety specifications. This recall affect products manufactured by Apotex Inc. and repackaged by Golden State Medical Supply. No injuries or adverse events have been reported to date.

Risk

The drug failed impurities and degradation specifications, which could potentially affect the medication's safety or quality. Patients should not stop taking their prescribed antidepressant medication without first consulting their doctor or pharmacist, as stopping abruptly can cause withdrawal symptoms.

What You Should Do

  1. This recall affects Paroxetine USP tablets in 10 mg, 20 mg, and 40 mg strengths packaged in 30-count, 90-count, and 1,000-count bottles by Golden State Medical Supply (GSMS).
  2. Affected products have National Drug Codes (NDC) 60429-734, 60429-735, or 60429-737 and expiration dates of August 31, 2024. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Golden State Medical Supply Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PAROXETINE tablets, USP, 10 mg
Variants: 10 mg, Tablet, 30-count bottle, 90-count bottle, 1000-count bottle
Lot Numbers:
GS041383 (Exp. 08/31/2024)
GS042141 (Exp. 08/31/2024)
GS040841 (Exp. 08/31/2024)
GS041384 (Exp. 08/31/2024)
GS042039 (Exp. 08/31/2024)
GS040910 (Exp. 08/31/2024)
GS041621 (Exp. 08/31/2024)
GS042237 (Exp. 08/31/2024)
NDC:
60429-734-30
60429-734-90
60429-734-10

Manufactured by Apotex, Inc., Toronto, Ontario, Canada; Packaged by GSMS, Incorporated, Camarillo, CA.

Product: PAROXETINE tablets, USP, 20 mg
Variants: 20 mg, Tablet, 90-count bottle, 1000-count bottle
Lot Numbers:
GS036696 (Exp. 08/31/2024)
GS037068 (Exp. 08/31/2024)
GS037934 (Exp. 08/31/2024)
GS038564 (Exp. 08/31/2024)
GS036381 (Exp. 08/31/2024)
GS036712 (Exp. 08/31/2024)
GS037116 (Exp. 08/31/2024)
GS037692 (Exp. 08/31/2024)
GS038388 (Exp. 08/31/2024)
NDC:
60429-735-90
60429-735-10

Manufactured by Apotex, Inc., Toronto, Ontario, Canada; Packaged by GSMS, Incorporated, Camarillo, CA.

Product: PAROXETINE tablets, USP, 40 mg
Variants: 40 mg, Tablet, 30-count bottle, 90-count bottle, 1000-count bottle
Lot Numbers:
GS036488 (Exp. 08/31/2024)
GS037091 (Exp. 08/31/2024)
GS037701 (Exp. 08/31/2024)
GS037090 (Exp. 08/31/2024)
GS037702 (Exp. 08/31/2024)
GS036677 (Exp. 08/31/2024)
GS037117 (Exp. 08/31/2024)
GS037699 (Exp. 08/31/2024)
NDC:
60429-737-30
60429-737-90
60429-737-10

Manufactured by Apotex, Inc., Toronto, Ontario, Canada; Packaged by GSMS, Incorporated, Camarillo, CA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93431
Status: Resolved
Manufacturer: Golden State Medical Supply Inc.
Sold By: Pharmacies
Manufactured In: Canada, United States
Units Affected: 3 products (1941 bottles; 2502 bottles; 5626 bottles)
Distributed To: Nationwide
Agency Last Updated: December 5, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.