Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Misoprostol recalled?

Not under an active recall. Misoprostol was recalled 12 times in the past — all now closed. Most recent: Apr 20, 2018.

Most common reason: Failed specification (7 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Misoprostol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Misoprostol recalls on record

none so far in 2026; 12 on record, newest first
Class III · Low risk

Cytotec (misoprostol)

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

Terminated Impurity / degradation Pfizer Inc. NDC 0025-1461-34 D-0424-2017
Class II · Moderate risk

Misoprostol 1% 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.

Terminated Cross-contamination Attix Pharmaceuticals D-802-2015
Class II · Moderate risk

Misoprostol

Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-649-2014
Class II · Moderate risk

MISOPROSTOL Tablet

Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-564-2014
Class II · Moderate risk

Arthrotec 75

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-4165-1 D-1379-2012