Direct Rx Losartan Pot/HCTZ Recall: FDA Class II

Why it was recalled

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Product description

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Lot numbers, UPCs & expiration codes

Lot: 25OC2116 Exp. 5/31/23

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0893-2022
Classification: Class II
Status: Terminated
Recall initiated: May 11, 2022
FDA report date: Jun 1, 2022
Quantity: 11 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Direct Rx

Original FDA data

Every field from FDA enforcement report D-0893-2022, exactly as published.

Show all FDA fields

City: Dawsonville
State: GA
Status: Terminated
Country: United States
Event ID: 90200
Address: 94 Worldwide Dr
Code information: Lot: 25OC2116 Exp. 5/31/23
Postal code: 30534-6828
Report date: Jun 1, 2022
Product type: Drugs
Recall number: D-0893-2022
Classification: Class II
Recalling firm: Direct Rx
Product quantity: 11 bottles
Termination date: Dec 2, 2022
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Voluntary / mandated: Voluntary: Firm initiated
Product description: Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Distribution pattern: FL
Recall initiation date: May 11, 2022
Initial firm notification: Letter
Center classification date: May 24, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0893-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Direct Rx Losartan Pot/HCTZ 100/12 Recall

Summary