Losartan and Losartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen - UPDATED

In November 2018, Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide. The recall affects 6 lots of losartan potassium – hydrochlorothiazide tablets distributed after October 8, 2018. One of the raw ingredients, losartan potassium, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). In December 2018, January 2019, Torrent recalled 10 lots of losartan potassium 100 mg tablets. The raw ingredient, losartan potassium, USP, made by Hetero Labs Limited, contains the contaminant NDEA. In February and June 2019, Macleods Pharmaceuticals recalled 32 lots of losartan potassium – hydrochlorothiazide tablets of various strengths because NDEA was detected in unacceptable levels. The raw ingredient for the Macloeds product was also made by Hetero Labs Limited. The International Agency for Research on Cancer classifies NDEA as a probable human carcinogen. It is found naturally occurring in certain foods, drinking water, air pollution, and industrial processes. No adverse events have been reported at this time.

In February 2019, Camber Pharmaceuticals, Inc. voluntarily recalled 87 lots of losartan potassium tablets. The active ingredient, losartan potassium, USP, made by Hetero Labs Limited, contains the contaminant N-nitroso N-Methyl 4-amino butyric acid (NMBA). In March 2019, Torrent voluntarily recalled 60 lots of losartan potassium tablets and 54 lots of losartan potassium tablets co-formulated with hydrochlorothiazide because NMBA was detected in unacceptable levels. In April 2019, Torrent expanded their voluntarily recall to 36 lots of losartan potassium tablets and 68 lots of losartan potassium – hydrochlorothiazide. In September 2019, Torrent expanded their voluntary recall to include 3 lots of losartan potassium tablets and 2 lots of losartan potassium – hydrochlorothiazide that tested positive for NMBA above 9.82 parts per million. The raw ingredient for the Torrent product was also made by Hetero Labs Limited. Several repackaged Camber and Torrent products have also been recalled. N-nitroso N-Methyl 4-amino butyric acid (NMBA) is a potential human carcinogen. No adverse events have been reported at this time. In April 2019, Teva voluntarily recalled 35 lots of losartan potassium tablets (6 lots of 25 mg tablets, 29 lots of 100 mg tablets) due to detection of NMBA. In June 2019, Teva expanded the recall to include 6 additional lots (2 lots of 50 mg tablets and 4 lots of 100 mg tablets). These lots were sold exclusively to Golden State Medical Supply (GSMS FG). The raw ingredient for Teva’s products was made by Hetero Labs Limited as well.

Pharmacies should cease distribution of, and quarantine all affected products. Return the recalled product per the instructions of each individual supplier. Patients should continue taking their medication until they can contact their healthcare provider to discuss alternative options. Patients with questions or concerns about this recall can contact Sandoz Inc. at 800-525-8747 or by email at usdrugsafety.operations@novartis.com; Torrent Pharmaceuticals by phone at 800-912-9561 or email at medinfo.torrent@apcerls.com; Qualanex (on behalf of Macloeds) by phone at 888-280-2042 or by email at recall@qualanex.com; Camber Pharmaceuticals at 866-495-1995; or Teva Pharmaceuticals at 888-838-2872 or by email druginfo@tevapharm.com. Consumers should report any adverse reactions from this product to their provider. Reactions may be reported to FDA through the MedWatch Adverse Event Reporting program at www.fda.gov/safety/medwatch/.

In April 2019, the FDA published a list of currently marketed ARB presentations and their nitrosamine assessment. The FDA plans to continually update this list as new information becomes available. The list can be found at www.fda.gov/drugs/drug-safety-and-availability/fdas-assessment-currently-marketed-arb-drug-products.

Additional information including affected bottles and lot numbers are available in the following links: