Eighty-seven lots of Losartan USP tablets sold in 25, 50, and 100 mg are being recalled due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA).

NMBA is a potential human carcinogen.

Losartan Potassium, USP, is used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles.

The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below:

NDC Name and Strength Count Lot# Expiry
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17026B Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17050 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17051 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17052 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17053 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17061 Oct-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18035 Dec-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18036 Dec-19
31722-700-05 Losartan Potassium Tablets USP 25 mg 500 LOP17026 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17006 May-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17025 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17068 Oct-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18037 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18038 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18039 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18057 Jan-20
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17028C Sep-19
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17064A Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17027 Sep-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17063 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17093 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17094 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17095 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17097A Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17105 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17107 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17004 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17028B Sep-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17048 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17049 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17056 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17073 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17074 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17076 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17096 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18077A Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18078 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18079 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18080 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18081 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18084 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18095 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18096 Mar-20
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17011 Aug-19
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17087 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17012 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17013 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17042 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17043 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17044 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17045 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18024 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18025 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18026 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18027 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18028 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18029 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18030 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17005 May-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17014 Aug-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17016 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17023 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17083 Oct-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17084 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17085 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17086 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18021 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18022 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18023 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18031 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18032 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18033 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18050 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18051 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18109 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18111 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18122 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18123 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18124 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18125 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18126 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18127 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18128 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18129 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18130 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18131C Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18133 Jun-20
 


Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals’ Med Line at 1-866-495-1995 Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


To date, Camber has not received any reports of adverse events related to this recall.