Medications & Supplements/Prescription Drugs

Novitium Pharma LLC: Ranitidine Capsules Recalled for NDMA Impurity (Potential Carcinogen)

Agency Publication Date: November 11, 2019

Summary

Novitium Pharma LLC has recalled approximately 41,250 bottles of Ranitidine capsules in 150 mg and 300 mg strengths because testing detected an impurity called N-Nitrosodimethylamine (NDMA). These prescription medications are used to treat conditions such as heartburn and stomach ulcers. Consumers should check their medicine bottles for the brand name 'Novitium Pharma' and the specific National Drug Code (NDC) numbers listed below. This voluntary recall was initiated after manufacturing deviations were discovered regarding the presence of this impurity.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer with long-term exposure. While no immediate injuries or illnesses have been reported, the levels of NDMA detected in these specific capsules exceed the limits considered safe by the FDA.

What You Should Do

Identify if you have the affected product by checking the bottle for the following NDC numbers: 70954-001-20 (150mg, 60ct), 70954-001-40 (150mg, 500ct), 70954-002-10 (300mg, 30ct), or 70954-002-40 (300mg, 100ct).
Verify if your bottle is part of the recall by looking for the lot number; all lots currently within their expiration dates are included in this recall.
Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and do not stop taking your medication without a replacement plan.
Return any unused product to the pharmacy where it was purchased for a refund and contact Novitium Pharma LLC at their East Windsor, New Jersey 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

Return unused product 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: Novitium Pharma Ranitidine Capsules 150 mg (60 capsules)

Model:

NDC 70954-001-20

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 150 mg (500 capsules)

Model:

NDC 70954-001-40

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 300 mg (30 capsules)

Model:

NDC 70954-002-10

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 300 mg (100 capsules)

Model:

NDC 70954-002-40

Lot Numbers:

all lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84147

Status: Resolved

Manufacturer: Novitium Pharma LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (19560 bottles; 2718 bottles; 12312 bottles; 6660 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

Identify if you have the affected product by checking the bottle for the following NDC numbers: 70954-001-20 (150mg, 60ct), 70954-001-40 (150mg, 500ct), 70954-002-10 (300mg, 30ct), or 70954-002-40 (300mg, 100ct).

Verify if your bottle is part of the recall by looking for the lot number; all lots currently within their expiration dates are included in this recall.

Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and do not stop taking your medication without a replacement plan.

Return any unused product to the pharmacy where it was purchased for a refund and contact Novitium Pharma LLC at their East Windsor, New Jersey 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: Novitium Pharma Ranitidine Capsules 150 mg (60 capsules)

Model:

NDC 70954-001-20

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 150 mg (500 capsules)

Model:

NDC 70954-001-40

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 300 mg (30 capsules)

Model:

NDC 70954-002-10

Lot Numbers:

all lots within expiry

Product: Novitium Pharma Ranitidine Capsules 300 mg (100 capsules)

Model:

NDC 70954-002-40

Lot Numbers:

all lots within expiry