PhotoTeva Pharmaceuticals USA is recalling 35 lots of bulk Losartan Potassium USP tablets used for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.

The product contains trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

The lots were sold exclusively to Golden State Medical Supply of Camarillo, Calif. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets.

Teva has not received any reports to date of adverse events related to the lots being recalled.

The finished product lots included in this voluntary recall and listed below were sold by Teva in bulk containers.

GSMS FG NDCsGSMS FG
NDC Description
GSMS FG Product LotsGSMS FG Expiration Dates
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01404506/2019
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01430506/2019
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01405406/2019
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01404406/2019
60429-316-10Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count BottleGS01481706/2019
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01517206/2019
60429-316-10Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count BottleGS01520406/2019
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01633812/2019
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01634101/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01634201/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01634301/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01634401/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01634501/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01653501/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01652401/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01653901/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01696901/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01697301/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01733701/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01738402/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01738501/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01753901/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01754001/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01754301/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01754201/2020
60429-318-10Losartan Potassium, Tablets, USP, 100 mg, 1,000 Count BottleGS01852402/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01798402/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01798502/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01798602/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01826302/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01826402/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01763402/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01765302/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01798002/2020
60429-316-30Losartan Potassium, Tablets, USP, 25 mg, 30 Count BottleGS01798102/2020
60429-318-90Losartan Potassium, Tablets, USP, 100 mg, 90 Count BottleGS01826502/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01672602/2020
60429-316-30Losartan Potassium, Tablets, USP, 25 mg, 30 Count BottleGS01695802/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01704502/2020
60429-316-90Losartan Potassium, Tablets, USP, 25 mg, 90 Count BottleGS01727602/2020
60429-316-30Losartan Potassium, Tablets, USP, 25 mg, 30 Count BottleGS01734102/2020
60429-316-10Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count BottleGS01831802/2020
60429-316-10Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count BottleGS01734202/2020
60429-316-10Losartan Potassium, Tablets, USP, 25 mg, 1,000 Count BottleGS01780802/2020

The bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label.

The recalled tablets are described as:

  • Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side.
  • Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

What to do

Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment.

Patients with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products may contact Teva Medical Information by at (888)838-2872, option 3, then, option 4, Monday-Friday, 9:00AM – 5:00PM (ET) with voicemail available 24 hours/day, 7 days/week, or by email at druginfo@tevapharm.com.

Patients wishing to return product may contact Teva’s product recall processor (Inmar) to obtain instructions and a return kit for returning their medication.

Contact Inmar at (877) 789-2065 from 9 am to 5 pm (ET) Monday – Friday) or by email Inmar at: tevarecalls@inmar.com.

Inmar will provide the materials needed to return their medication and instructions for reimbursement.


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