Micro Labs Usa, Inc S Losartan Potassium Tablets Recall

Why it was recalled

Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

Product description

LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10

Lot numbers, UPCs & expiration codes

Lot #LJAG003, Expiry: 05/2015

Where it was sold

U.S. Including: New York

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-0253-2015
Classification: Class II
Status: Terminated
Recall initiated: Sep 22, 2014
FDA report date: Nov 26, 2014
Quantity: 144 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Micro Labs Usa, Inc S

Original FDA data

Every field from FDA enforcement report D-0253-2015, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 69590
Address: 104 Carnegie Ctr
Address (line 2): Te 216
Code information: Lot #LJAG003, Expiry: 05/2015
Postal code: 08540-6232
Report date: Nov 26, 2014
Product type: Drugs
Recall number: D-0253-2015
Classification: Class II
Recalling firm: Micro Labs Usa, Inc S
Product quantity: 144 bottles
Termination date: Dec 22, 2015
Reason for recall: Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Voluntary / mandated: Voluntary: Firm initiated
Product description: LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
Distribution pattern: U.S. Including: New York
Recall initiation date: Sep 22, 2014
Initial firm notification: Letter
Center classification date: Nov 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0253-2015, published Nov 26, 2014. View the source record (openFDA) · FDA enforcement reports

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

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