Medications & Supplements/Over-the-Counter

Preferred Pharmaceuticals, Inc: Ranitidine Tablets Recalled Due to Presence of NDMA Impurity

Agency Publication Date: December 10, 2019

Summary

Preferred Pharmaceuticals, Inc. is recalling 316 bottles of Ranitidine (150 mg) over-the-counter (OTC) tablets due to the detection of NDMA, a probable human carcinogen. The recall affects specific 30-count and 60-count bottles manufactured by Amneal Pharmaceuticals and distributed in California and Florida. This action was taken because the product was found to have levels of the impurity that do not meet current manufacturing standards.

Risk

NDMA is classified as a probable human carcinogen; laboratory testing has detected this impurity in some ranitidine products, which may pose a long-term health risk to consumers if ingested over time.

What You Should Do

Check your medicine cabinet for Ranitidine Tablets, USP 150 mg, OTC, in either 30-count or 60-count bottles.
Verify the Lot Numbers and Expiration Dates on the bottle label: look for Lot I2519H (Exp. 12/20), Lot I2719O (Exp. 12/20), Lot J1419O (Exp. 12/20), or Lot J2819L (Exp. 12/20).
Check for National Drug Codes (NDC) 68788-7078-03 (for 30-count bottles) or 68788-7078-06 (for 60-count bottles) to confirm your product is affected.
Immediately contact your healthcare provider or pharmacist to discuss alternative treatments and for guidance on how to safely manage your condition.
Return any unused tablets from the affected lots to the pharmacy where they were purchased for a refund.
Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California office for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare consultation and 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 Tablets, USP 150 mg, OTC (30 count bottle)

Model:

NDC 68788-7078-03

Lot Numbers:

I2519H (Exp. 12/20)

I2719O (Exp. 12/20)

J1419O (Exp. 12/20)

J2819L (Exp. 12/20)

Date Ranges: Exp. 12/20

Product: Ranitidine Tablets, USP 150 mg, OTC (60 count bottle)

Model:

NDC 68788-7078-06

Lot Numbers:

I2519H (Exp. 12/20)

I2719O (Exp. 12/20)

J1419O (Exp. 12/20)

J2819L (Exp. 12/20)

Date Ranges: Exp. 12/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84422

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc

Manufactured In: United States

Units Affected: 316 bottles

Distributed To: California, Florida

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 Ranitidine Tablets, USP 150 mg, OTC, in either 30-count or 60-count bottles.

Verify the Lot Numbers and Expiration Dates on the bottle label: look for Lot I2519H (Exp. 12/20), Lot I2719O (Exp. 12/20), Lot J1419O (Exp. 12/20), or Lot J2819L (Exp. 12/20).

Check for National Drug Codes (NDC) 68788-7078-03 (for 30-count bottles) or 68788-7078-06 (for 60-count bottles) to confirm your product is affected.

Immediately contact your healthcare provider or pharmacist to discuss alternative treatments and for guidance on how to safely manage your condition.

Return any unused tablets from the affected lots to the pharmacy where they were purchased for a refund.

Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California office for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Ranitidine Tablets, USP 150 mg, OTC (30 count bottle)

Model:

NDC 68788-7078-03

Lot Numbers:

I2519H (Exp. 12/20)

I2719O (Exp. 12/20)

J1419O (Exp. 12/20)

J2819L (Exp. 12/20)

Date Ranges: Exp. 12/20

Product: Ranitidine Tablets, USP 150 mg, OTC (60 count bottle)

Model:

NDC 68788-7078-06

Lot Numbers:

I2519H (Exp. 12/20)

I2719O (Exp. 12/20)

J1419O (Exp. 12/20)

J2819L (Exp. 12/20)

Date Ranges: Exp. 12/20