Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
Is Isosorbide recalled?
Not under an active recall.
Isosorbide was recalled 11 times in the past — all now closed. Most recent: Nov 2, 2018.
Most common reason: Labeling / mix-up (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Isosorbide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Isosorbide recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
Class II · Moderate risk
Isosorbide Dinitrate active pharmaceutical ingredient packaged in…
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
ISOSORBIDE MONONITRATE ER Tablet
Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383
Class II · Moderate risk
Isosorbide Mononitrate
Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.
Class II · Moderate risk
ISOSORBIDE MONONITRATE Tablet
Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.
Class II · Moderate risk
ISOSORBIDE DINITRATE ER Tablet
Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.
Class II · Moderate risk
Isosorbide Dinitrate
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
Class II · Moderate risk
Isosorbide Dinitrate
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.