CLASS II ONGOING Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report

Losartan Potassium Tablets USP, 50 mg recalled by Camber Pharmaceuticals

Camber Pharmaceuticals is recalling Losartan Potassium Tablets USP, 50 mg, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19; b) LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19; c) LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20

NDC31722-700, 31722-701, 31722-702

UPC0331722702300, 0331722700900, 0331722701303

Quantity recalled69712 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1042-2019
FDA event ID: 82281
Recalling firm: Camber Pharmaceuticals, Piscataway, NJ
Brand: Losartan Potassium
Manufacturer: Camber Pharmaceuticals, Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2019
FDA classified: 21 Mar 2019
Reported: 27 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

28 Feb 2019	Recall initiated by company
21 Mar 2019	Classified by FDA	+21 days
27 Mar 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

Where it was distributed

Nationwide

Questions about this recall

Is Losartan Potassium Tablets USP, 50 mg recalled?

Yes. Camber Pharmaceuticals recalled Losartan Potassium Tablets USP, 50 mg on 28 Feb 2019. The recall is Class II and its status is Ongoing. Recall number D-1042-2019.

Why was it recalled?

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Which lots are affected?

a) LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19; b) LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19; c) LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Camber Pharmaceuticals

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17 May 2023Drug	CLASS I	Atovaquone Oral Suspension USP, 750 mg recalledAtovaquone	Camber Pharmaceuticals	Sterility	Nationwide
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27 Mar 2019Drug	CLASS II	Losartan Potassium Tablets USP, 25 mg recalled by Camber PharmaceuticalsLosartan Potassium	Camber Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Losartan Potassium Tablets USP, 100 mg recalledLosartan Potassium	Camber Pharmaceuticals	Nitrosamine Impurity	Nationwide

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Reported	Class	Recall	Company	Reason	Where
12 Jul 2023Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Foreign Material	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 50 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
8 Jun 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Potency & Assay	Nationwide