Medications & Supplements/Prescription Drugs

Direct Rx: Ranitidine Recalled Due to Presence of NDMA Impurity

Agency Publication Date: October 5, 2020

Summary

Direct Rx is recalling approximately 106 bottles of Ranitidine 150 mg and 300 mg prescription tablets, a medication used to treat stomach acid and ulcers. The recall was initiated because testing detected the presence of N-Nitrosodimethylamine (NDMA), an impurity classified as a probable human carcinogen. These products were packaged and distributed by Direct Rx to patients in Florida and Georgia between 2019 and 2020.

Risk

The medication contains NDMA, a substance that may increase the risk of cancer with long-term exposure. While no immediate injuries have been reported, the presence of this impurity exceeds acceptable safety limits for pharmaceutical products.

What You Should Do

Check your prescription bottles for Ranitidine 150 mg (60 or 90 count) or Ranitidine 300 mg (30 count) distributed by Direct Rx.
Verify the NDC and Lot numbers on your packaging: For 150 mg 60-count bottles, check for NDC 61919-339-60 and Lot 09AU1911 (Exp. 02/28/2022). For 150 mg 90-count bottles, check for NDC 61919-339-90 and Lot 09SE1904 (Exp. 03/31/2022).
For 300 mg 30-count bottles, verify NDC 61919-455-30 and Lot 29JA1915 (Exp. 09/30/2021).
Contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before you stop taking your medication.
Return any remaining unused medication to your pharmacy for a refund and contact Direct Rx at their Dawsonville, GA location 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

Contact healthcare provider or pharmacist and return product.

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

Affected Products

Product: Ranitidine 150 mg (60 Tabs)

Model:

NDC 61919-339-60

Recall #: D-0016-2021

Lot Numbers:

09AU1911 (Exp. 02/28/2022)

Date Ranges: Expiration date 02/28/2022

Product: Ranitidine 150 mg (90 Tabs)

Model:

NDC 61919-339-90

Recall #: D-0016-2021

Lot Numbers:

09SE1904 (Exp. 03/31/2022)

Date Ranges: Expiration date 03/31/2022

Product: Ranitidine 300 mg (30 Tabs)

Model:

NDC 61919-455-30

Recall #: D-0017-2021

Lot Numbers:

29JA1915 (Exp. 09/30/2021)

Date Ranges: Expiration date 09/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86498

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx

Manufactured In: United States

Units Affected: 2 products (a) 54 bottles; b) 26 bottles; 26 bottles)

Distributed To: Florida, Georgia

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 Ranitidine 150 mg (60 or 90 count) or Ranitidine 300 mg (30 count) distributed by Direct Rx.

Verify the NDC and Lot numbers on your packaging: For 150 mg 60-count bottles, check for NDC 61919-339-60 and Lot 09AU1911 (Exp. 02/28/2022). For 150 mg 90-count bottles, check for NDC 61919-339-90 and Lot 09SE1904 (Exp. 03/31/2022).

For 300 mg 30-count bottles, verify NDC 61919-455-30 and Lot 29JA1915 (Exp. 09/30/2021).

Contact your healthcare provider or pharmacist immediately to discuss alternative treatment options before you stop taking your medication.

Return any remaining unused medication to your pharmacy for a refund and contact Direct Rx at their Dawsonville, GA location 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: Ranitidine 150 mg (60 Tabs)

Model:

NDC 61919-339-60

Recall #: D-0016-2021

Lot Numbers:

09AU1911 (Exp. 02/28/2022)

Date Ranges: Expiration date 02/28/2022

Product: Ranitidine 150 mg (90 Tabs)

Model:

NDC 61919-339-90

Recall #: D-0016-2021

Lot Numbers:

09SE1904 (Exp. 03/31/2022)

Date Ranges: Expiration date 03/31/2022

Product: Ranitidine 300 mg (30 Tabs)

Model:

NDC 61919-455-30

Recall #: D-0017-2021

Lot Numbers:

29JA1915 (Exp. 09/30/2021)

Date Ranges: Expiration date 09/30/2021