Class II · Moderate risk
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
Is Mesalamine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Mesalamine (10 total). Check the affected lots below.
Most common reason: Dissolution failure (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mesalamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mesalamine recalls on record
none so far in 2026; 10 on record, newest first
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class II · Moderate risk
Mesalamine
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class II · Moderate risk
Mesalamine Dr
Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014.
Class II · Moderate risk
MESALAMINE CR Capsule
Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014.
Class II · Moderate risk
MESALAMINE CR Capsule
Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.
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