Medications & Supplements/Prescription Drugs

Amneal Pharmaceuticals of New York, LLC: Nizatidine Oral Solution Recalled Due to Potential Impurity (NDMA)

Agency Publication Date: April 24, 2020

Summary

Amneal Pharmaceuticals is recalling 11,258 bottles of Nizatidine Oral Solution (15 mg/mL) because the medication may contain N-Nitrosodimethylamine (NDMA) at levels higher than allowed by the FDA. Nizatidine is a prescription medication used to treat stomach ulcers and acid reflux. Consumers who have these 480 mL bottles should contact their healthcare provider or pharmacist immediately to discuss alternative treatments. Do not stop taking your medication without consulting a medical professional first.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer with long-term exposure. While no injuries or illnesses have been reported for this specific recall, the chemical was found at levels exceeding the safety limits established by the FDA due to manufacturing deviations.

What You Should Do

Identify your medication by checking the label for Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) in 480 mL bottles with NDC 60846-301-15.
Check the bottle for the following specific lot numbers and expiration dates: Lot 06598004A (Exp 04/2020), Lot 06599001A (Exp 12/2020), or Lot 06599002A (Exp 12/2020).
Contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as suddenly stopping treatment for certain conditions can cause health risks.
Return any unused product from the affected lots to your pharmacy for a refund and to ensure it is disposed of properly.
Contact Amneal Pharmaceuticals or the distributor, Gemini Laboratories, LLC, for further instructions regarding this recall.
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

Return to pharmacy for refund

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

Affected Products

Product: Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) (480 mL bottle)

Model:

NDC 60846-301-15

D-1253-2020

Lot Numbers:

06598004A (Exp 04/2020)

06599001A (Exp 12/2020)

06599002A (Exp 12/2020)

Date Ranges: April 2020, December 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85386

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: Gemini Laboratories, LLC; Pharmacies

Manufactured In: United States

Units Affected: 11258 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

Risk

What You Should Do

Identify your medication by checking the label for Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) in 480 mL bottles with NDC 60846-301-15.

Check the bottle for the following specific lot numbers and expiration dates: Lot 06598004A (Exp 04/2020), Lot 06599001A (Exp 12/2020), or Lot 06599002A (Exp 12/2020).

Contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as suddenly stopping treatment for certain conditions can cause health risks.

Return any unused product from the affected lots to your pharmacy for a refund and to ensure it is disposed of properly.

Contact Amneal Pharmaceuticals or the distributor, Gemini Laboratories, LLC, for further instructions regarding this recall.

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.