Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals, Inc: Losartan Potassium Tablets Recalled Due to Presence of NMBA Impurity

Agency Publication Date: March 22, 2019

Summary

Preferred Pharmaceuticals, Inc. has recalled approximately 530 units of Losartan Potassium Tablets (50 mg), a prescription medication used to treat high blood pressure. The recall was initiated because testing identified an impurity called N-Methylnitrosobutyric acid (NMBA), which does not meet safety standards. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment and obtain a replacement medication before stopping use of the recalled tablets.

Risk

The tablets contain NMBA, a known impurity that may pose a health risk over long-term exposure. While no immediate injuries have been reported, the presence of this substance represents a deviation from current Good Manufacturing Practice (CGMP) standards.

What You Should Do

Check your prescription bottle to see if you have Losartan Potassium Tablets, USP, 50 mg distributed by Preferred Pharmaceuticals, Inc.
For 30-count bottles (NDC 68788-0048-03), check for lot numbers C2218C (expiry 9/2020) and D1318E (expiry 10/2020).
For 90-count bottles (NDC 68788-0048-09), check for lot numbers C2719J (expiry 9/2020) and E1818B (expiry 10/2020).
Contact your healthcare provider or pharmacist immediately for guidance; do not stop taking your medication until you have a replacement, as stopping blood pressure medication abruptly can be dangerous.
Return any unused product to your pharmacy for a refund and contact Preferred Pharmaceuticals, Inc. at 1250 N Lakeview Ave Ste O, Anaheim, CA 92807 for further instructions.
For additional questions, 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 and return to pharmacy.

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

Affected Products

Product: Losartan Potassium Tablets, USP, 50 mg (30-count bottle)

Model:

NDC: 68788-0048-03

Recall #: D-1051-2019

Lot Numbers:

C2218C (Exp 9/2020)

D1318E (Exp 10/2020)

Date Ranges: September 2020, October 2020

Product: Losartan Potassium Tablets, USP, 50 mg (90-count bottle)

Model:

NDC: 68788-0048-09

Recall #: D-1051-2019

Lot Numbers:

C2719J (Exp 9/2020)

E1818B (Exp 10/2020)

Date Ranges: September 2020, October 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82335

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc

Sold By: Preferred Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 530

Distributed To: California, Georgia, Indiana

Agency Last Updated: March 29, 2019

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 bottle to see if you have Losartan Potassium Tablets, USP, 50 mg distributed by Preferred Pharmaceuticals, Inc.

For 30-count bottles (NDC 68788-0048-03), check for lot numbers C2218C (expiry 9/2020) and D1318E (expiry 10/2020).

For 90-count bottles (NDC 68788-0048-09), check for lot numbers C2719J (expiry 9/2020) and E1818B (expiry 10/2020).

Contact your healthcare provider or pharmacist immediately for guidance; do not stop taking your medication until you have a replacement, as stopping blood pressure medication abruptly can be dangerous.

Return any unused product to your pharmacy for a refund and contact Preferred Pharmaceuticals, Inc. at 1250 N Lakeview Ave Ste O, Anaheim, CA 92807 for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Losartan Potassium Tablets, USP, 50 mg (30-count bottle)

Model:

NDC: 68788-0048-03

Recall #: D-1051-2019

Lot Numbers:

C2218C (Exp 9/2020)

D1318E (Exp 10/2020)

Date Ranges: September 2020, October 2020

Product: Losartan Potassium Tablets, USP, 50 mg (90-count bottle)

Model:

NDC: 68788-0048-09

Recall #: D-1051-2019

Lot Numbers:

C2719J (Exp 9/2020)

E1818B (Exp 10/2020)

Date Ranges: September 2020, October 2020