Additional Firms Recall Losartan

More recalls of losartan products are being issued after trace amounts of N-Methylnitrosobutyric acid (NMBA) were detected in an active pharmaceutical ingredient used to manufacture the medications.

The April 17, 2019, US Food and Drug Administration (FDA) Enforcement Report includes the following recalls:

• RemedyRepack Inc. is voluntarily recalling 30-count blister cards of 50-mg losartan tablets (NDC 70518-0588-01) from lot J0328416-101518 (Exp. 10/19) distributed to a customer in Miami, Florida; 
• HJ Harkins Co. Inc, dba Pharma Pac, is voluntarily recalling 100-mg losartan potassium tablets (NDC 76519-1033-03) from lot LTO00EW (Exp. 11/19) distributed to a California physician’s office; 
• Torrent Pharma Inc. is voluntarily recalling 25-mg losartan potassium tablets, 90-count bottles (NDC 13668-113-90) and 1000-count bottles (NDC 13668-113-10), from lots 4DU1E005, 4DU1E006, 4DU1E007, and 4DU1E008 (Exp. 1/31/21) distributed throughout the United States and in Puerto Rico;
• Torrent Pharma Inc. is voluntarily recalling 50-mg losartan potassium tablets, 30-count bottles (NDC 13668-409-30) from lot 4DU2D077 (Exp. 10/31/20); 90-count bottles (NDC 13668-409-90) from lots 4DU2D087 (Exp. 10/31/20), 4DU2E023, 4DU2E024, 4DU2E026, 4DU2E027, 4DU2E028, 4DU2E029, and 4DU2E020 (Exp. 1/31/21), and 4O50E007 and 4O50E008 (Exp. 8/31/21); and 1000-count bottles (NDC 13668-409-10) from lots 4DU2D067, 4DU2D069, 4DU2D063, 4DU2D064, 4DU2D065, and 4DU2D066 (Exp. 9/30/20), 4DU2D084, 4DU2D085, 4DU2D083, 4DU2D082, 4DU2D072, 4DU2D077, 4DU2D078, 4DU2D079, 4DU2D081, 4DU2D080, 4DU2D070, 4DU2D073, 4DU2D074, 4DU2D075, 4DU2D086, 4DU2D088, and 4DU2D089 (Exp. 10/31/20), 4DU2E019, 4DU2E021, 4DU2E022, and 4DU2E025 (Exp. 1/31/21); 4DU2E032, 4DU2E033, 4DU2E034, 4DU2E035, 4DU2E036, 4DU2E037, 4DU2E038, 4DU2E039, and 4DU2E041 (Exp. 2/28/21), and 4DU2E103, 4DU2E101, and 4DU2E102 (Exp. 6/30/21) distributed throughout the United States and in Puerto Rico; 
• Torrent Pharma Inc. is voluntarily recalling 100-mg losartan potassium tablets, 90-count bottles (NDC 13668-115-90) from lots 4DU3E014 and 4DU3E015 (Exp. 1/31/21), and 4DU3E065 (Exp. 7/31/21); and 1000-count bottles (NDC 13668-115-10) from lots 4DU3D018 (Exp. 11/30/20), and 4DU3E062 and 4DU3E063 (Exp. 6/30/21) distributed throughout the United States and in Puerto Rico; 
• Torrent Pharma Inc. is voluntarily recalling losartan potassium/hydrochlorothiazide tablets, 50 mg/12.5 mg, 30-count bottles (NDC 13668-116-30) from lot BEF7D017 (Exp. 6/30/20); 90-count bottles (NDC 13668-116-90) from lots BEF7D010 and BEF7D011 (Exp. 4/30/20), BEF7D018 (Exp. 6/30/20), BEF7D009 (Exp. 4/30/20), and 4P02E002, 4P02E003, and 4P02E004 (Exp. 1/31/21); and 1000-count bottles (NDC 13668-116-10) from lots BEF7D008, BEF7D012, and BEF7D013 (Exp. 4/30/20), BEF7D022 (Exp. 8/31/20), BEF7D049 (Exp. 11/30/20), and 4P02E005 and 4P02E006 (Exp. 1/31/21) distributed throughout the United States and in Puerto Rico;  
• Torrent Pharma Inc. is voluntarily recalling losartan potassium/hydrochlorothiazide tablets, 100 mg/12.5 mg, 30-count bottles (NDC 13668-117-30) from lot BEF8D058 (Exp. 11/30/20); and 90-count bottles (NDC 13668-117-90) from lots BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, and BEF8D008 (Exp. 3/31/20), BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, and BEF8D022 (Exp. 4/30/20), BEF8D054, BEF8D055, and BEF8D056 (Exp. 10/31/20), and BEF8D057 (Exp. 11/30/20) distributed throughout the United States and in Puerto Rico; and 
• Torrent Pharma Inc. is voluntarily recalling losartan potassium/hydrochlorothiazide tablets, 100 mg/25 mg, 30-count bottles (NDC 13668-118-30) from lot BEF6D038 (Exp. 4/30/20); 90-count bottles (NDC 13668-118-90) from lots BEF6D030 and BEF6D031 (Exp. 4/30/20), BEF6D047, BEF6D048, BEF6D049, BEF6D050, and BEF6D051 (Exp. 7/31/20), BEF6D082, BEF6D083, BEF6D084, BEF6D085, BEF6D086, and BEF6D087 (Exp. 10/31/20), and 4P04E003, 4P04E004, 4P04E005, and 4P04E006 (Exp. 1/31/21); and 1000-count bottles (NDC 13668-118-10) from lots 4P04E007, 4P04E008, and 4P04E009 (Exp. 1/31/21) distributed throughout the United States and in Puerto Rico.

The FDA has designated the recalls Class II, communicating use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Losartan is a prescription drug used to treat patients with high blood pressure, reduce stroke risk in patients with high blood pressure and an enlarged heart, and treat kidney disease in patients with diabetes.  

—Jolynn Tumolo