Class II · Moderate risk
Irbesartan Bulk Active Pharmaceutical Ingredient.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Is Irbesartan recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Irbesartan (31 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Irbesartan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Irbesartan recalls on record
none so far in 2026; 31 on record, newest first
Class III · Low risk
Irbesartan and Hydrochlorothiazide Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Class III · Low risk
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class II · Moderate risk
Irbesartan active pharmaceutical ingredient packaged in varying…
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.
Class II · Moderate risk
Irbesartan
Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the following drug: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD32757_7, EXP: 5/13/2014.
Class II · Moderate risk
Irbesartan
Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014.
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