Additional Recalls Issued for Losartan Potassium Tablets

Two firms have issued new recalls for losartan potassium tablets, citing US Food and Drug Administration (FDA) confirmation of the presence of N-Methylnitrosobutyric acid (NMBA) in the drug, according to the May 29, 2019, FDA Enforcement Report.

The latest recalls were voluntarily initiated by Heritage Pharmaceuticals Inc. and Golden State Medical Supply Inc. in early May and designated Class II by the FDA in mid-May. The designation communicates use of the recalled losartan tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Heritage Pharmaceuticals Inc. is recalling the following products, which were manufactured by Vivimed Life Sciences and distributed throughout the United States: 

• losartan potassium tablets, 50 mg, 1000 tablets (NDC 23155-645-10), from lots CLO17007A, CLO17008A, and CLO17009A (Exp. 11/19); 
• losartan potassium tablets, 100 mg, 90 tablets (NDC 23155-646-09), from lots CLO17012A (Exp. 11/19), CLO17013A (Exp. 11/19), CLO18002A (Exp. 1/20), CLO18020A (Exp. 4/20), CLO18021A (Exp. 4/20), and CLO18022A (Exp. 4/20); 
• losartan potassium tablets, 50 mg, 90 tablets (NDC 23155-645-09), from lots CLO17009B (Exp. 11/19), CLO17010A (Exp. 11/19), and CLO18023A (Exp. 4/20);
• losartan potassium tablets, 100 mg, 1000 tablets (NDC 23155-646-10), from lots CLO17014A (Exp. 12/19), CLO17015A (Exp. 1/20), CLO17016A (Exp. 1/20), CLO17017A (Exp. 1/20), CLO18001A (Exp. 1/20), and CLO18002B (Exp. 1/20); and
• losartan potassium tablets, 25 mg, 90 tablets (NDC 23155-644-09), from lot CLO17006A (Exp. 11/19). 

Golden State Medical Supply Inc. is recalling the following products, which were distributed to US government and Veterans Affairs accounts in Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, and Texas:

• losartan potassium tablets, 25 mg, 30-count bottles (NDC 60429-316-30) from lots GS017981 (Exp. 2/20), GS016958 (Exp. 2/20), and GS017341 (Exp. 2/20);
• losartan potassium tablets, 25 mg, 90-count bottles (NDC 60429-316-90) from lots GS015172 (Exp. 6/19), GS017634 (Exp. 2/20), GS017653 (Exp. 2/20), GS017980 (Exp. 2/20), GS017276 (Exp. 2/20), GS017045 (Exp. 2/20), and GS016726 (Exp. 2/20); 
• losartan potassium tablets, 25 mg, 1000-count bottles (NDC 60429-316-10) from lots GS015204 (Exp. 6/19), GS018318 (Exp. 2/20), GS014817 (Exp. 6/19), GS017342 (Exp. 2/20), and GS017808 (Exp. 2/20); 
• losartan potassium tablets, 100 mg, 90-count bottles (NDC 60429-318-90) from lots GS014045 (Exp. 6/19), GS014305 (Exp. 6/19), GS014044 (Exp. 6/19), GS016535 (Exp. 1/20), GS016524 (Exp. 1/20), GS017384 (Exp. 2/20), GS017385 (Exp. 1/20), GS017539 (Exp. 1/20), GS017540 (Exp. 1/20), GS017543 (Exp. 1/20), GS017542 (Exp. 1/20), GS017984 (Exp. 2/20), GS017985 (Exp. 2/20), GS017986 (Exp. 2/20), GS018263 (Exp. 2/20), GS018264 (Exp. 2/20), and GS018265 (Exp. 2/20); and 
• losartan potassium tablets, 100 mg, 1000-count bottles (NDC 60429-318-10) from lots GS014054 (Exp. 6/19), GS016338 (Exp. 12/19), GS016341 (Exp. 1/20), GS016342 (Exp. 1/20), GS016343 (Exp. 1/20), GS016344 (Exp. 1/20), GS016345 (Exp. 1/20), GS016539 (Exp. 1/20), GS016969 (Exp. 1/20), GS016973 (Exp. 1/20), GS017337 (Exp. 1/20), and GS018524 (Exp. 2/20). 

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