Direct Rx Losartan Pot/HCTZ Recall: FDA Class II

Why it was recalled

CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.

Product description

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90

Lot numbers, UPCs & expiration codes

Lot: 12DE1806 Exp. 01/31/2021

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-0032-2021
Classification: Class II
Status: Terminated
Recall initiated: Mar 12, 2019
FDA report date: Oct 7, 2020
Quantity: 33 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Direct Rx

Original FDA data

Every field from FDA enforcement report D-0032-2021, exactly as published.

Show all FDA fields

City: Dawsonville
State: GA
Status: Terminated
Country: United States
Event ID: 86487
Address: 94 Worldwide Dr
Code information: Lot: 12DE1806 Exp. 01/31/2021
Postal code: 30534-6828
Report date: Oct 7, 2020
Product type: Drugs
Recall number: D-0032-2021
Classification: Class II
Recalling firm: Direct Rx
Product quantity: 33 bottles
Termination date: Sep 21, 2021
Reason for recall: CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Distribution pattern: FL
Recall initiation date: Mar 12, 2019
Initial firm notification: Letter
Center classification date: Oct 12, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0032-2021, published Oct 7, 2020. 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 50/12 Recall

Summary