Medications & Supplements/Prescription Drugs

Losartan Potassium 50 mg Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: April 26, 2022

Summary

This recall affects approximately 466 blister cards of Losartan Potassium (50 mg), a prescription medication used to treat high blood pressure. RemedyRepack Inc. is recalling these tablets because testing detected levels of an impurity called "AZIDO" that exceed the safety limits set by the FDA. The affected products were distributed in 30-count and 60-count blister cards to pharmacy customers in Alaska and Pennsylvania. No injuries or illnesses have been reported in connection with this recall to date.

Risk

Testing revealed levels of the AZIDO impurity above acceptable limits. Long-term exposure to this impurity at high levels may pose health risks, though no immediate adverse effects have been reported.

What You Should Do

This recall affects Losartan Potassium 50 mg Tablets sold in 30-count blister cards (NDC 70518-3282-1) and 60-count blister cards (NDC 70518-3282-0) by RemedyRepack Inc.
Check your medication packaging for lot number B1467803-120621 with an expiration date of 06/30/2022, or lot number J0585793-121721 with an expiration date of 12/31/2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.
Call 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

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Losartan Potassium 50 mg Tablet (30-count)

Variants: 50 mg, 30-count blister card, Tablet, Rx Only

Lot Numbers:

B1467803-120621 (Exp 06/30/2022)

J0585793-121721 (Exp 12/31/2022)

NDC:

70518-3282-1

Manufactured by Lupin Pharma, Baltimore, MD.

Product: Losartan Potassium 50 mg Tablet (60-count)

Variants: 50 mg, 60-count blister card, Tablet, Rx Only

Lot Numbers:

B1467803-120621 (Exp 06/30/2022)

J0585793-121721 (Exp 12/31/2022)

NDC:

70518-3282-0

Manufactured by Lupin Pharma, Baltimore, MD.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89968

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Pharmacy customers in AK and PA

Manufactured In: United States

Units Affected: 433/30 count blister cards, 33/60 count blister cards

Distributed To: Alaska, Pennsylvania

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

This recall affects Losartan Potassium 50 mg Tablets sold in 30-count blister cards (NDC 70518-3282-1) and 60-count blister cards (NDC 70518-3282-0) by RemedyRepack Inc.

Check your medication packaging for lot number B1467803-120621 with an expiration date of 06/30/2022, or lot number J0585793-121721 with an expiration date of 12/31/2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.

Call 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

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Losartan Potassium 50 mg Tablet (30-count)

Variants: 50 mg, 30-count blister card, Tablet, Rx Only

Lot Numbers:

B1467803-120621 (Exp 06/30/2022)

J0585793-121721 (Exp 12/31/2022)

NDC:

70518-3282-1

Manufactured by Lupin Pharma, Baltimore, MD.

Product: Losartan Potassium 50 mg Tablet (60-count)

Variants: 50 mg, 60-count blister card, Tablet, Rx Only

Lot Numbers:

B1467803-120621 (Exp 06/30/2022)

J0585793-121721 (Exp 12/31/2022)

NDC:

70518-3282-0

Manufactured by Lupin Pharma, Baltimore, MD.