Medications & Supplements/Prescription Drugs

Sandoz, Inc: Ranitidine Hydrochloride Capsules Recalled for Unexpected Impurity (NDMA)

Agency Publication Date: October 7, 2019

Summary

Sandoz, Inc. is recalling approximately 250,232 bottles of Ranitidine Hydrochloride Capsules (150mg and 300mg), a prescription medication used to treat stomach acid conditions. The recall was initiated because testing detected trace amounts of N-nitrosodimethylamine (NDMA), an impurity that is classified as a probable human carcinogen. These prescription medications were manufactured in India and distributed across the United States in bottles of 30, 60, and 500 capsules. Consumers should consult with their healthcare provider to discuss alternative treatment options before stopping the medication.

Risk

The capsules contain trace amounts of NDMA, a substance that may increase the risk of cancer with long-term exposure. While no immediate injuries or adverse events have been reported for this specific recall, the presence of this impurity exceeds acceptable safety limits.

What You Should Do

Check your prescription bottles for Sandoz Ranitidine Hydrochloride 150mg (60-count) with NDC 0781-2855-60 and lot numbers HC9266 (Exp 4/30/2020), HD1865 (Exp 4/30/2020), HP9441 (Exp 9/30/2020), JK7994 (Exp 8/31/2021), or JK8659 (Exp 8/31/2021).
Check your prescription bottles for Sandoz Ranitidine Hydrochloride 150mg (500-count) with NDC 0781-2855-05 and lot numbers HD1862 (Exp 4/30/2020), HP9438 (Exp 9/30/2020), HP9439 (Exp 9/30/2020), or HP9440 (Exp 9/30/2020).
Check your prescription bottles for Sandoz Ranitidine Hydrochloride 300mg (30-count) with NDC 0781-2865-31 and lot numbers HD8625 (Exp 4/30/2020), HD9275 (Exp 4/30/2020), HU2207 (Exp 8/31/2020), HX6676 (Exp 3/31/2021), or HX6677 (Exp 3/31/2021).
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the recalled medicine.
Return any unused portions of the recalled medication to your pharmacy for a refund and contact Sandoz, Inc. at their Princeton, NJ headquarters for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund for unused medication

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

Affected Products

Product: Sandoz Ranitidine Hydrochloride Capsules 150mg (60 Capsules)

Model:

NDC 0781-2855-60

Lot Numbers:

HC9266 (Exp 4/30/2020)

HD1865 (Exp 4/30/2020)

HP9441 (Exp 9/30/2020)

JK7994 (Exp 8/31/2021)

JK8659 (Exp 8/31/2021)

Date Ranges: Expiration dates through 8/31/2021

Product: Sandoz Ranitidine Hydrochloride Capsules 150mg (500 Capsules)

Model:

NDC 0781-2855-05

Lot Numbers:

HD1862 (Exp 4/30/2020)

HP9438 (Exp 9/30/2020)

HP9439 (Exp 9/30/2020)

HP9440 (Exp 9/30/2020)

Date Ranges: Expiration dates through 9/30/2020

Product: Sandoz Ranitidine Hydrochloride Capsules 300mg (30 Capsules)

Model:

NDC 0781-2865-31

Lot Numbers:

HD8625 (Exp 4/30/2020)

HD9275 (Exp 4/30/2020)

HU2207 (Exp 8/31/2020)

HX6676 (Exp 3/31/2021)

HX6677 (Exp 3/31/2021)

Date Ranges: Expiration dates through 3/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83875

Status: Resolved

Manufacturer: Sandoz, Inc

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 3 products (100,314 bottles; 13,130 bottles; 136,788 bottles)

Distributed To: Nationwide

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

Check your prescription bottles for Sandoz Ranitidine Hydrochloride 150mg (60-count) with NDC 0781-2855-60 and lot numbers HC9266 (Exp 4/30/2020), HD1865 (Exp 4/30/2020), HP9441 (Exp 9/30/2020), JK7994 (Exp 8/31/2021), or JK8659 (Exp 8/31/2021).

Check your prescription bottles for Sandoz Ranitidine Hydrochloride 150mg (500-count) with NDC 0781-2855-05 and lot numbers HD1862 (Exp 4/30/2020), HP9438 (Exp 9/30/2020), HP9439 (Exp 9/30/2020), or HP9440 (Exp 9/30/2020).

Check your prescription bottles for Sandoz Ranitidine Hydrochloride 300mg (30-count) with NDC 0781-2865-31 and lot numbers HD8625 (Exp 4/30/2020), HD9275 (Exp 4/30/2020), HU2207 (Exp 8/31/2020), HX6676 (Exp 3/31/2021), or HX6677 (Exp 3/31/2021).

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the recalled medicine.

Return any unused portions of the recalled medication to your pharmacy for a refund and contact Sandoz, Inc. at their Princeton, NJ headquarters for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Sandoz Ranitidine Hydrochloride Capsules 150mg (60 Capsules)

Model:

NDC 0781-2855-60

Lot Numbers:

HC9266 (Exp 4/30/2020)

HD1865 (Exp 4/30/2020)

HP9441 (Exp 9/30/2020)

JK7994 (Exp 8/31/2021)

JK8659 (Exp 8/31/2021)

Date Ranges: Expiration dates through 8/31/2021

Product: Sandoz Ranitidine Hydrochloride Capsules 150mg (500 Capsules)

Model:

NDC 0781-2855-05

Lot Numbers:

HD1862 (Exp 4/30/2020)

HP9438 (Exp 9/30/2020)

HP9439 (Exp 9/30/2020)

HP9440 (Exp 9/30/2020)

Date Ranges: Expiration dates through 9/30/2020

Product: Sandoz Ranitidine Hydrochloride Capsules 300mg (30 Capsules)

Model:

NDC 0781-2865-31

Lot Numbers:

HD8625 (Exp 4/30/2020)

HD9275 (Exp 4/30/2020)

HU2207 (Exp 8/31/2020)

HX6676 (Exp 3/31/2021)

HX6677 (Exp 3/31/2021)

Date Ranges: Expiration dates through 3/31/2021