Medications & Supplements/Prescription Drugs

Direct Rx Losartan Potassium/HCTZ Recalled for Azido Impurity Levels

Agency Publication Date: May 24, 2022

Summary

Direct Rx is recalling 28 bottles of Losartan Potassium/Hydrochlorothiazide (HCTZ) combination tablets, a medication used to treat high blood pressure. The recall affects three different strengths (50/12.5 mg, 100/12.5 mg, and 100/25 mg) because tests detected an impurity called AZIDO at levels exceeding safety standards. No incidents or injuries related to this recall have been reported to date. These products were packaged and distributed by Direct Rx and sold in Florida.

Risk

Long-term exposure to AZIDO impurities in blood pressure medication may pose potential health risks. Patients should not stop taking their blood pressure medication without first consulting a doctor, as the risks of untreated high blood pressure often outweigh the risks associated with this impurity.

What You Should Do

This recall affects Direct Rx brand Losartan Potassium and Hydrochlorothiazide (HCTZ) combination tablets sold in 90-count bottles in Florida.
Identify your medication by checking the National Drug Code (NDC) and lot numbers on the label. Affected products include Losartan Pot/HCTZ 50/12.5 mg (NDC 72189-297-90), 100/12.5 mg (NDC 72189-290-90), and 100/25 mg (NDC 72189-289-90). 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 Direct Rx for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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 (50/12.5 mg) 90 Tabsby Direct Rx

Variants: 50/12.5 mg, 90 Tablets

Lot Numbers:

19NO2108 (Exp. 1/31/25)

19NO2114 (Exp. 1/31/25)

22NO2126 (Exp. 1/31/25)

NDC:

72189-297-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.

Product: Losartan Pot/HCTZ (100/25 mg) 90 Tabsby Direct Rx

Variants: 100/25 mg, 90 Tablets

Lot Numbers:

08NO2102 (Exp. 1/31/25)

17NO2118 (Exp. 1/31/25)

18NO2123 (Exp. 1/31/25)

25OC2114 (Exp. 1/31/25)

22NO2105 (Exp. 1/31/25)

NDC:

72189-289-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.

Product: Losartan Pot/HCTZ (100/12.5 mg) 90 Tabsby Direct Rx

Variants: 100/12.5 mg, 90 Tablets

Lot Numbers:

25OC2116 (Exp. 5/31/23)

NDC:

72189-290-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90200

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx

Manufactured In: United States

Units Affected: 3 products (11 bottles; 6 bottles; 11 bottles)

Distributed To: 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

Risk

What You Should Do

This recall affects Direct Rx brand Losartan Potassium and Hydrochlorothiazide (HCTZ) combination tablets sold in 90-count bottles in Florida.

Identify your medication by checking the National Drug Code (NDC) and lot numbers on the label. Affected products include Losartan Pot/HCTZ 50/12.5 mg (NDC 72189-297-90), 100/12.5 mg (NDC 72189-290-90), and 100/25 mg (NDC 72189-289-90). 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 Direct Rx for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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 (50/12.5 mg) 90 Tabsby Direct Rx

Variants: 50/12.5 mg, 90 Tablets

Lot Numbers:

19NO2108 (Exp. 1/31/25)

19NO2114 (Exp. 1/31/25)

22NO2126 (Exp. 1/31/25)

NDC:

72189-297-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.

Product: Losartan Pot/HCTZ (100/25 mg) 90 Tabsby Direct Rx

Variants: 100/25 mg, 90 Tablets

Lot Numbers:

08NO2102 (Exp. 1/31/25)

17NO2118 (Exp. 1/31/25)

18NO2123 (Exp. 1/31/25)

25OC2114 (Exp. 1/31/25)

22NO2105 (Exp. 1/31/25)

NDC:

72189-289-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.

Product: Losartan Pot/HCTZ (100/12.5 mg) 90 Tabsby Direct Rx

Variants: 100/12.5 mg, 90 Tablets

Lot Numbers:

25OC2116 (Exp. 5/31/23)

NDC:

72189-290-90

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. Manufactured For Macleods Pharma USA, Inc. Plainsboro, NJ 08540.