Medications & Supplements/Prescription Drugs

Golden State Medical Supply Inc.: Ranitidine Capsules Recalled for NDMA Impurity

Agency Publication Date: November 10, 2019

Summary

Golden State Medical Supply is recalling several lots of Ranitidine capsules, a medication used to treat heartburn and stomach ulcers, due to the detection of an impurity called N-nitrosodimethylamine (NDMA). The recall affects Ranitidine 150 mg in 500-count bottles and Ranitidine 300 mg in 100-count bottles. NDMA is a substance that is classified as a probable human carcinogen, meaning it could increase the risk of cancer with long-term exposure. Consumers should contact their doctor or pharmacist to discuss alternative treatments.

Risk

The product was found to contain an impurity called NDMA, which is a known environmental contaminant and a probable human carcinogen. While NDMA is common at low levels in water and foods, exposure to higher levels over time may increase the risk of developing cancer.

What You Should Do

Identify your medication by checking the label for Ranitidine Capsules 150 mg (NDC 51407-097-05) in 500-count bottles or Ranitidine Capsules 300 mg (NDC 51407-098-01) in 100-count bottles.
Check for affected 150 mg lot numbers: GS023970, GS026108, GS026099, GS026838, GS025702, GS027272 (all Exp. 10/31/2020) and GS027273 (Exp. 05/31/2021).
Check for affected 300 mg lot numbers: GS023971, GS025527, GS025526, GS026114, GS025813 (all Exp. 10/31/2020); GS027555 (Exp. 7/31/2021); GS026189 (Exp. 10/31/2021); and GS026190, GS026220, GS026584, GS027139, GS027554 (all Exp. 05/31/2021).
Contact your healthcare provider or pharmacist for guidance on alternative medications before you stop taking this prescription drug.
Return any unused product to your pharmacy for a refund and contact Golden State Medical Supply Inc. for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Drug recall remedy instructions

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ranitidine Capsules 150 mg (500 count bottle)

Model:

NDC 51407-097-05

Recall #: D-0307-2020

Lot Numbers:

GS023970 (Exp. 10/31/2020)

GS026108 (Exp. 10/31/2020)

GS026099 (Exp. 10/31/2020)

GS026838 (Exp. 10/31/2020)

GS025702 (Exp. 10/31/2020)

GS027272 (Exp. 10/31/2020)

GS027273 (Exp. 05/31/2021)

Date Ranges: Expiration dates between 10/31/2020 and 05/31/2021

Product: Ranitidine Capsules 300 mg (100 count bottle)

Model:

NDC 51407-098-01

Recall #: D-0308-2020

Lot Numbers:

GS023971 (Exp. 10/31/2020)

GS025527 (Exp. 10/31/2020)

GS025526 (Exp. 10/31/2020)

GS026114 (Exp. 10/31/2020)

GS025813 (Exp. 10/31/2020)

GS026189 (Exp. 10/31/2021)

GS027555 (Exp. 7/31/2021)

GS026190 (Exp. 5/31/2021)

GS026220 (Exp. 05/31/2021)

GS026584 (Exp. 05/31/2021)

GS027139 (Exp. 05/31/2021)

GS027554 (Exp. 05/31/2021)

Date Ranges: Expiration dates between 10/31/2020 and 10/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84233

Status: Resolved

Manufacturer: Golden State Medical Supply Inc.

Sold By: Pharmacies

Manufactured In: United States

Distributed To: Arizona, Iowa, Massachusetts, Missouri

Agency Last Updated: November 29, 2019

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 · 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.

Summary

What You Should Do

Identify your medication by checking the label for Ranitidine Capsules 150 mg (NDC 51407-097-05) in 500-count bottles or Ranitidine Capsules 300 mg (NDC 51407-098-01) in 100-count bottles.

Check for affected 150 mg lot numbers: GS023970, GS026108, GS026099, GS026838, GS025702, GS027272 (all Exp. 10/31/2020) and GS027273 (Exp. 05/31/2021).

Check for affected 300 mg lot numbers: GS023971, GS025527, GS025526, GS026114, GS025813 (all Exp. 10/31/2020); GS027555 (Exp. 7/31/2021); GS026189 (Exp. 10/31/2021); and GS026190, GS026220, GS026584, GS027139, GS027554 (all Exp. 05/31/2021).

Contact your healthcare provider or pharmacist for guidance on alternative medications before you stop taking this prescription drug.

Return any unused product to your pharmacy for a refund and contact Golden State Medical Supply Inc. for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Ranitidine Capsules 150 mg (500 count bottle)

Model:

NDC 51407-097-05

Recall #: D-0307-2020

Lot Numbers:

GS023970 (Exp. 10/31/2020)

GS026108 (Exp. 10/31/2020)

GS026099 (Exp. 10/31/2020)

GS026838 (Exp. 10/31/2020)

GS025702 (Exp. 10/31/2020)

GS027272 (Exp. 10/31/2020)

GS027273 (Exp. 05/31/2021)

Date Ranges: Expiration dates between 10/31/2020 and 05/31/2021

Product: Ranitidine Capsules 300 mg (100 count bottle)

Model:

NDC 51407-098-01

Recall #: D-0308-2020

Lot Numbers:

GS023971 (Exp. 10/31/2020)

GS025527 (Exp. 10/31/2020)

GS025526 (Exp. 10/31/2020)

GS026114 (Exp. 10/31/2020)

GS025813 (Exp. 10/31/2020)

GS026189 (Exp. 10/31/2021)

GS027555 (Exp. 7/31/2021)

GS026190 (Exp. 5/31/2021)

GS026220 (Exp. 05/31/2021)

GS026584 (Exp. 05/31/2021)

GS027139 (Exp. 05/31/2021)

GS027554 (Exp. 05/31/2021)

Date Ranges: Expiration dates between 10/31/2020 and 10/31/2021