Medications & Supplements/Prescription Drugs

Lupin Losartan Pot./HCTZ Recalled for Excessive Impurity Levels

Agency Publication Date: May 27, 2022

Summary

Direct Rx has recalled 81 bottles of Losartan Potassium and Hydrochlorothiazide (100/12.5 mg), a medication used to treat high blood pressure that was manufactured for Lupin Pharmaceuticals. Testing found that certain batches contain azido impurity levels that exceed acceptable safety limits. The recall includes specific lots of 30-count and 90-count bottles sold in several southern states. No injuries or adverse reactions have been reported in connection with this recall.

Risk

The medication contains azido impurities, which are considered potential mutagens. Long-term exposure to these impurities at levels above safety limits can potentially increase the risk of cancer.

What You Should Do

This recall affects Losartan Potassium and Hydrochlorothiazide 100/12.5 mg tablets manufactured for Lupin Pharmaceuticals and distributed by Direct Rx in 30-count and 90-count bottles.
Check the lot number and expiration date printed on your medication bottle to see if it is included in this recall. Affected lot numbers include 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, and 13SE2113. See the Affected Products section below for the full list of affected codes.
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 the manufacturer for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

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 Pot./HCTZ (100/12.5 mg)by Lupin Pharmaceuticals

Variants: 30-count bottle, 90-count bottle, 100/12.5 mg tablets

Lot Numbers:

11MY2103 (Exp. 11/30/22)

05JA2106 (Exp. 6/30/22)

20MY2115 (Exp. 11/30/22)

22JU2118 (Exp. 12/31/22)

29JY2113 (Exp. 12/31/22)

13SE2113 (Exp. 2/28/23)

NDC:

72189-167-30

72189-167-90

Packaged and Distributed By: Direct Rx. Manufactured For: Lupin Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90161

Status: Resolved

Manufacturer: Direct Rx

Sold By: pharmacies

Manufactured In: United States

Units Affected: 81 bottles

Distributed To: Alabama, Georgia, Florida, Louisiana

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 and Hydrochlorothiazide 100/12.5 mg tablets manufactured for Lupin Pharmaceuticals and distributed by Direct Rx in 30-count and 90-count bottles.

Check the lot number and expiration date printed on your medication bottle to see if it is included in this recall. Affected lot numbers include 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, and 13SE2113. See the Affected Products section below for the full list of affected codes.

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 the manufacturer for further instructions.

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

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 Pot./HCTZ (100/12.5 mg)by Lupin Pharmaceuticals

Variants: 30-count bottle, 90-count bottle, 100/12.5 mg tablets

Lot Numbers:

11MY2103 (Exp. 11/30/22)

05JA2106 (Exp. 6/30/22)

20MY2115 (Exp. 11/30/22)

22JU2118 (Exp. 12/31/22)

29JY2113 (Exp. 12/31/22)

13SE2113 (Exp. 2/28/23)

NDC:

72189-167-30

72189-167-90

Packaged and Distributed By: Direct Rx. Manufactured For: Lupin Pharmaceuticals, Inc.