Medications & Supplements/Prescription Drugs

American Health Packaging: Ranitidine Oral Solution Recalled Due to NDMA Impurity Presence

Agency Publication Date: December 29, 2019

Summary

American Health Packaging has recalled 1,692 cases of Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, a prescription medication used to treat stomach acid conditions. The recall was initiated because the product may contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. These products were distributed nationwide across the United States in cases of 40 and 50 unit-dose cups.

Risk

The product was found to contain NDMA, a substance that may increase the risk of cancer in humans following long-term exposure. While no immediate injuries have been reported, the presence of this impurity violates manufacturing quality standards.

What You Should Do

Check your medication packaging for 'Ranitidine Syrup' or 'Ranitidine Oral Solution USP', 15 mg/mL (150 mg/10 mL per cup) distributed by American Health Packaging.
For cases of 40 cups (NDC 60687-260-23), look for lot numbers 183723, 184278 (Exp 10/31/2020), or 187652 (Exp 05/31/2021).
For cases of 50 cups (NDC 60687-260-69), look for lot numbers 177874 (Exp 01/31/2020), 178413 (Exp 02/29/2020), 183449 (Exp 10/31/2020), 184445 (Exp 12/31/2020), 186563 (Exp 03/31/2021), or 187691 (Exp 05/31/2021).
Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and for guidance on whether to continue taking the medication.
Return any unused portion of the recalled medicine to the pharmacy where you purchased it for a refund.
Contact American Health Packaging or the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL - Case of 40 cups

Model:

NDC 60687-260-23

D-0631-2020

Lot Numbers:

183723 (Exp 10/31/2020)

184278 (Exp 10/31/2020)

187652 (Exp 05/31/2021)

Date Ranges: 10/31/2020, 05/31/2021

Product: Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL - Case of 50 cups

Model:

NDC 60687-260-69

D-0631-2020

Lot Numbers:

177874 (Exp 01/31/2020)

178413 (Exp 02/29/2020)

183449 (Exp 10/31/2020)

184445 (Exp 12/31/2020)

186563 (Exp 03/31/2021)

187691 (Exp 05/31/2021)

Date Ranges: 01/31/2020, 02/29/2020, 10/31/2020, 12/31/2020, 03/31/2021, 05/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84208

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1,692 cases of 40 and 50 cups

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 medication packaging for 'Ranitidine Syrup' or 'Ranitidine Oral Solution USP', 15 mg/mL (150 mg/10 mL per cup) distributed by American Health Packaging.

For cases of 40 cups (NDC 60687-260-23), look for lot numbers 183723, 184278 (Exp 10/31/2020), or 187652 (Exp 05/31/2021).

For cases of 50 cups (NDC 60687-260-69), look for lot numbers 177874 (Exp 01/31/2020), 178413 (Exp 02/29/2020), 183449 (Exp 10/31/2020), 184445 (Exp 12/31/2020), 186563 (Exp 03/31/2021), or 187691 (Exp 05/31/2021).

Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and for guidance on whether to continue taking the medication.

Return any unused portion of the recalled medicine to the pharmacy where you purchased it for a refund.

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

Affected Products

Product: Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL - Case of 40 cups

Model:

NDC 60687-260-23

D-0631-2020

Lot Numbers:

183723 (Exp 10/31/2020)

184278 (Exp 10/31/2020)

187652 (Exp 05/31/2021)

Date Ranges: 10/31/2020, 05/31/2021

Product: Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL - Case of 50 cups

Model:

NDC 60687-260-69

D-0631-2020

Lot Numbers:

177874 (Exp 01/31/2020)

178413 (Exp 02/29/2020)

183449 (Exp 10/31/2020)

184445 (Exp 12/31/2020)

186563 (Exp 03/31/2021)

187691 (Exp 05/31/2021)

Date Ranges: 01/31/2020, 02/29/2020, 10/31/2020, 12/31/2020, 03/31/2021, 05/31/2021