Yes — there is an active recall. 37 ongoing FDA recalls mention Losartan (117 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Losartan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: MIDODRINE HCL, Tablet, 2.5 mg, NDC 00185004001, Pedigree: W003265, EXP: 6/17/2014.
Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD46312_22, EXP: 4/30/2014.
Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014; LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet,
Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, NDC 00093312901, Pedigree: AD65323_4, EXP: 5/29/2014.
Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 60505267109, Pedigree: AD21965_4, EXP: 5/1/2014.
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