drugs MODERATE Updated 2018-12-05

Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, U

See all recalls from Sandoz, Inc →

Recalled Product

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Issued by

FDA

Affected States: OH
Lot/Code Info: Lot #: JB8912; Exp. 06/2020

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Sandoz Losartan Potassium and →
View official government recall