Medications & Supplements/Prescription Drugs

PD-Rx Losartan Potassium Tablets Recalled for Elevated AZIDO Impurities

Agency Publication Date: June 27, 2022

Summary

PD-Rx Pharmaceuticals is recalling 3,448 bottles of Losartan Potassium (losartan) tablets in 25 mg, 50 mg, and 100 mg strengths. The recall was issued because the medication was found to contain levels of an impurity called AZIDO that exceed acceptable safety limits. These tablets are used to treat high blood pressure and are sold in 90-count bottles. No injuries or illnesses have been reported to date, but patients should consult their doctor before stopping the medication.

Risk

Elevated levels of AZIDO impurities are considered a potential risk when consumed over long periods. While no immediate injuries have been reported, the levels observed in these specific lots were above the limits allowed by safety standards.

What You Should Do

This recall affects PD-Rx Pharmaceuticals brand Losartan Potassium Tablets, USP (25 mg, 50 mg, and 100 mg) sold in 90-tablet bottles.
To identify if your medication is affected, check the bottle label for NDC codes 72789-163-90, 72789-164-90, or 72789-165-90 and the lot number and expiration date. 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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 Tablets, USP (25 mg, 90 Tablets)

Variants: 25 mg, Tablet

UPC Codes:

372789163901

Lot Numbers:

D21C18 (Exp. 09/30/22)

E21A28 (Exp. 09/30/22)

E21C04 (Exp. 09/30/22)

E21D59 (Exp. 09/30/22)

G21B65 (Exp. 09/30/22)

H21A12 (Exp. 09/30/22)

H21D42 (Exp. 09/30/22)

K21D19 (Exp. 10/31/22)

A22A73 (Exp. 10/31/22)

NDC:

72789-163-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.

Product: Losartan Potassium Tablets, USP (50 mg, 90 Tablets)

Variants: 50 mg, Tablet

UPC Codes:

372789164908

Lot Numbers:

D21D63 (Exp. 11/30/22)

E21A73 (Exp. 11/30/22)

E21D35 (Exp. 11/30/22)

F21A28 (Exp. 11/30/22)

F21D04 (Exp. 09/30/22)

G21B03 (Exp. 11/30/22)

G21E23 (Exp. 11/30/22)

H21B46 (Exp. 11/30/22)

H21D46 (Exp. 08/31/23)

I21B67 (Exp. 01/31/23)

J21A26 (Exp. 01/31/23)

J21C44 (Exp. 01/31/23)

NDC:

72789-164-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.

Product: Losartan Potassium Tablets, USP (100 mg, 90 Tablets)

Variants: 100 mg, Tablet

UPC Codes:

372789165905

Lot Numbers:

G21C26 (Exp. 07/31/22)

H21B96 (Exp. 07/31/22)

I21B39 (Exp. 07/31/22)

I21C44 (Exp. 07/31/22)

D21F35 (Exp. 10/31/22)

E21A66 (Exp. 10/31/22)

E21C72 (Exp. 10/31/22)

E21F01 (Exp. 10/31/22)

F21C15 (Exp. 10/31/22)

F21E19 (Exp. 10/31/22)

G21B14 (Exp. 10/31/22)

K21A61 (Exp. 11/30/22)

L21A45 (Exp. 11/30/22)

NDC:

72789-165-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90383

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 3 products (1441 bottles; 687 bottles; 1320 bottles)

Distributed To: Nationwide

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 PD-Rx Pharmaceuticals brand Losartan Potassium Tablets, USP (25 mg, 50 mg, and 100 mg) sold in 90-tablet bottles.

To identify if your medication is affected, check the bottle label for NDC codes 72789-163-90, 72789-164-90, or 72789-165-90 and the lot number and expiration date. 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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 Tablets, USP (25 mg, 90 Tablets)

Variants: 25 mg, Tablet

UPC Codes:

372789163901

Lot Numbers:

D21C18 (Exp. 09/30/22)

E21A28 (Exp. 09/30/22)

E21C04 (Exp. 09/30/22)

E21D59 (Exp. 09/30/22)

G21B65 (Exp. 09/30/22)

H21A12 (Exp. 09/30/22)

H21D42 (Exp. 09/30/22)

K21D19 (Exp. 10/31/22)

A22A73 (Exp. 10/31/22)

NDC:

72789-163-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.

Product: Losartan Potassium Tablets, USP (50 mg, 90 Tablets)

Variants: 50 mg, Tablet

UPC Codes:

372789164908

Lot Numbers:

D21D63 (Exp. 11/30/22)

E21A73 (Exp. 11/30/22)

E21D35 (Exp. 11/30/22)

F21A28 (Exp. 11/30/22)

F21D04 (Exp. 09/30/22)

G21B03 (Exp. 11/30/22)

G21E23 (Exp. 11/30/22)

H21B46 (Exp. 11/30/22)

H21D46 (Exp. 08/31/23)

I21B67 (Exp. 01/31/23)

J21A26 (Exp. 01/31/23)

J21C44 (Exp. 01/31/23)

NDC:

72789-164-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.

Product: Losartan Potassium Tablets, USP (100 mg, 90 Tablets)

Variants: 100 mg, Tablet

UPC Codes:

372789165905

Lot Numbers:

G21C26 (Exp. 07/31/22)

H21B96 (Exp. 07/31/22)

I21B39 (Exp. 07/31/22)

I21C44 (Exp. 07/31/22)

D21F35 (Exp. 10/31/22)

E21A66 (Exp. 10/31/22)

E21C72 (Exp. 10/31/22)

E21F01 (Exp. 10/31/22)

F21C15 (Exp. 10/31/22)

F21E19 (Exp. 10/31/22)

G21B14 (Exp. 10/31/22)

K21A61 (Exp. 11/30/22)

L21A45 (Exp. 11/30/22)

NDC:

72789-165-90

Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Manufactured by: Vivimed Life Sciences Private Limited.