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Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

Drug Recall

Official source record

Recall number
D-1043-2019
Event ID
82281
Classification
Class II
Status
Ongoing
Recalling company
Camber Pharmaceuticals Inc
Reason for recall
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Report date
March 27, 2019
Recall initiation date
February 28, 2019
Termination date
Not terminated as of this source record
Distribution pattern
Nationwide

Drug product identifiers

Manufacturer
Camber Pharmaceuticals, Inc.
Brand name
LOSARTAN POTASSIUM
Generic name
LOSARTAN POTASSIUM
Substance name
LOSARTAN POTASSIUM
Product NDCs
31722-700; 31722-701; 31722-702
Package NDCs
31722-700-05; 31722-700-10; 31722-700-30; 31722-700-60; 31722-700-90; 31722-701-05; 31722-701-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-702-05; 31722-702-10; 31722-702-30; 31722-702-60; 31722-702-90
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Official guidance and record verification

Public Health Trace does not provide medical advice. The information below explains how to interpret this record and links to relevant official government sources. Review the linked official source for the current, authoritative information.

Compare the medication name, manufacturer, NDC, package information, and lot number on your medication with the official FDA record to see whether it matches.

Public Health Trace last retrieved this record on July 28, 2026.

Public Health Trace republishes FDA's drug recall record and does not provide medical or medication instructions -- review the official FDA record and FDA's general drug recall guidance (linked below) for what to do.

View the official FDA record · General drug recall guidance from FDA

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.

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