Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Ranitidine Tablets, Capsules, and Syrup Recalled for NDMA Contamination

Agency Publication Date: November 26, 2019

Summary

AuroMedics Pharma LLC has voluntarily recalled approximately 295,368 units of Ranitidine products, including DG Health Acid Reducer tablets, Aurobindo capsules, and Aurobindo oral syrup. These products, commonly used to treat heartburn and stomach ulcers, are being recalled because testing detected N-nitrosodimethylamine (NDMA) at levels above acceptable limits. NDMA is a substance that is classified as a probable human carcinogen based on laboratory tests. Consumers should contact their healthcare provider or pharmacist for alternative treatment options and return any unused portions of the affected lots for a refund.

Risk

The products contain N-nitrosodimethylamine (NDMA), a chemical contaminant that is classified as a probable human carcinogen. Long-term exposure to levels of NDMA above recommended safety thresholds may increase the risk of developing cancer.

What You Should Do

Check your medicine cabinet for the following affected products: DG Health Acid Reducer Ranitidine Tablets (150 mg), Aurobindo Ranitidine Capsules (150 mg and 300 mg), or Ranitidine Oral Solution Syrup (15 mg/mL).
Verify if your specific product is part of the recall by matching the NDC and Lot Numbers on the packaging. For DG Health 150 mg tablets (NDC 55910-092-79), look for Lot NBSB19001DA3 with expiration FEB 2021. For the Ranitidine Syrup (NDC 65862-431-74), check for lots UI1519001-A, UI1519002-A, UI1519003-A, or UI1519004-A.
For Aurobindo Ranitidine Capsules (150 mg and 300 mg), check the bottles for lot numbers beginning with 'RA' such as RA1518001-A through RA1519004-A and expiration dates ranging from July 2020 to May 2021.
If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before stopping the medication.
Return any unused portions of the recalled medication to the place of purchase for a full refund and contact AuroMedics Pharma LLC for further return 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

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

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

Affected Products

Product: DG Health Acid Reducer Ranitidine Tablets 150 mg (8-count carton)

Model:

NDC 55910-092-79

D-0526-2020

Lot Numbers:

NBSB19001DA3 (Exp FEB 2021)

Date Ranges: February 2021

Product: Aurobindo Ranitidine Capsules 150 mg (60-count bottle)

Model:

NDC 59651-144-60

D-0527-2020

Lot Numbers:

RA1518001-A (Exp Jul 2020)

RA1518002-A (Exp Jul 2020)

RA1518005-B (Exp Aug 2020)

RA1518006-A (Exp Aug 2020)

RA1519003-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Product: Aurobindo Ranitidine Capsules 300 mg (30-count bottle)

Model:

NDC 59651-145-30

D-0528-2020

Lot Numbers:

RA3018001-A (Exp Jul 2020)

RA3018002-A (Exp Jul 2020)

RA3018003-A (Exp Jul 2020)

RA3018004-A (Exp Aug 2020)

RA3018005-A (Exp Aug 2020)

RA3018006-A (Exp Aug 2020)

RA3018007-A (Exp Sep 2020)

RA3018008-A (Exp Sep 2020)

RA3018009-A (Exp Sep 2020)

RA3018010-A (Exp Oct 2020)

RA3019001-A (Exp Jan 2021)

RA3019002-A (Exp Jan 2021)

RA3019003-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Product: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) (474 mL bottle)

Model:

NDC 65862-431-74

D-0529-2020

Lot Numbers:

UI1519001-A

UI1519002-A

UI1519003-A

UI1519004-A

Product: Aurobindo Ranitidine Capsules 150 mg (500 count bottle)

Model:

NDC 59651-144-05

D-0530-2020

Lot Numbers:

RA1518002-B (Exp Jul 2020)

RA1518003-A (Exp Jul 2020)

RA1518004-A (Exp Aug 2020)

RA1518005-A (Exp Aug 2020)

RA1518007-A (Exp Sep 2020)

RA1518008-A (Exp Sep 2020)

RA1518009-A (Exp Sep 2020)

RA1518010-A (Exp Oct 2020)

RA1518011-A (Exp Nov 2020)

RA1518012-A (Exp Nov 2020)

RA1518013-A (Exp Nov 2020)

RA1518014-A (Exp Nov 2020)

RA1518015-A (Exp Nov 2020)

RA1519003-B (Exp May 2021)

RA1519004-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84218

Status: Active

Manufacturer: AuroMedics Pharma LLC

Sold By: Dolgencorp LLC; Aurobindo Pharma USA, Inc.; Dollar General

Manufactured In: United States, India

Units Affected: 5 products (69,696 bottles; 45,456 bottles; 134,160 bottles; 19320 bottles; 26,736 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 medicine cabinet for the following affected products: DG Health Acid Reducer Ranitidine Tablets (150 mg), Aurobindo Ranitidine Capsules (150 mg and 300 mg), or Ranitidine Oral Solution Syrup (15 mg/mL).

Verify if your specific product is part of the recall by matching the NDC and Lot Numbers on the packaging. For DG Health 150 mg tablets (NDC 55910-092-79), look for Lot NBSB19001DA3 with expiration FEB 2021. For the Ranitidine Syrup (NDC 65862-431-74), check for lots UI1519001-A, UI1519002-A, UI1519003-A, or UI1519004-A.

For Aurobindo Ranitidine Capsules (150 mg and 300 mg), check the bottles for lot numbers beginning with 'RA' such as RA1518001-A through RA1519004-A and expiration dates ranging from July 2020 to May 2021.

If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before stopping the medication.

Return any unused portions of the recalled medication to the place of purchase for a full refund and contact AuroMedics Pharma LLC for further return 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: DG Health Acid Reducer Ranitidine Tablets 150 mg (8-count carton)

Model:

NDC 55910-092-79

D-0526-2020

Lot Numbers:

NBSB19001DA3 (Exp FEB 2021)

Date Ranges: February 2021

Product: Aurobindo Ranitidine Capsules 150 mg (60-count bottle)

Model:

NDC 59651-144-60

D-0527-2020

Lot Numbers:

RA1518001-A (Exp Jul 2020)

RA1518002-A (Exp Jul 2020)

RA1518005-B (Exp Aug 2020)

RA1518006-A (Exp Aug 2020)

RA1519003-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Product: Aurobindo Ranitidine Capsules 300 mg (30-count bottle)

Model:

NDC 59651-145-30

D-0528-2020

Lot Numbers:

RA3018001-A (Exp Jul 2020)

RA3018002-A (Exp Jul 2020)

RA3018003-A (Exp Jul 2020)

RA3018004-A (Exp Aug 2020)

RA3018005-A (Exp Aug 2020)

RA3018006-A (Exp Aug 2020)

RA3018007-A (Exp Sep 2020)

RA3018008-A (Exp Sep 2020)

RA3018009-A (Exp Sep 2020)

RA3018010-A (Exp Oct 2020)

RA3019001-A (Exp Jan 2021)

RA3019002-A (Exp Jan 2021)

RA3019003-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Product: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) (474 mL bottle)

Model:

NDC 65862-431-74

D-0529-2020

Lot Numbers:

UI1519001-A

UI1519002-A

UI1519003-A

UI1519004-A

Product: Aurobindo Ranitidine Capsules 150 mg (500 count bottle)

Model:

NDC 59651-144-05

D-0530-2020

Lot Numbers:

RA1518002-B (Exp Jul 2020)

RA1518003-A (Exp Jul 2020)

RA1518004-A (Exp Aug 2020)

RA1518005-A (Exp Aug 2020)

RA1518007-A (Exp Sep 2020)

RA1518008-A (Exp Sep 2020)

RA1518009-A (Exp Sep 2020)

RA1518010-A (Exp Oct 2020)

RA1518011-A (Exp Nov 2020)

RA1518012-A (Exp Nov 2020)

RA1518013-A (Exp Nov 2020)

RA1518014-A (Exp Nov 2020)

RA1518015-A (Exp Nov 2020)

RA1519003-B (Exp May 2021)

RA1519004-A (Exp May 2021)

Date Ranges: July 2020 - May 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84218

Status: Active

Manufacturer: AuroMedics Pharma LLC

Sold By: Dolgencorp LLC; Aurobindo Pharma USA, Inc.; Dollar General

Manufactured In: United States, India

Units Affected: 5 products (69,696 bottles; 45,456 bottles; 134,160 bottles; 19320 bottles; 26,736 bottles)

Distributed To: Nationwide