Mesalamine Tablets Recalled for Manufacturing Equipment Microbial Contamination
Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. Microbial contamination was identified in stagnant water within manufacturing equipment, but no specific pathogen was identified and no product contamination has been reported. Per the severity rubric, precautionary recalls with unidentified microbial contamination and no reported harm are classified as Moderate (2).
Plain-English summary
Mesalamine Delayed-Release Tablets, USP 1.2 g are being recalled by Sun Pharmaceutical Industries Inc. The recall results from current good manufacturing practice (CGMP) deviations. Specifically, microbial contamination was reported in stagnant water in a duct of the manufacturing equipment.
The recall affects 10,690 bottles distributed nationwide in the USA. The affected lots and expiration dates are: DNE0875A (01/31/2025), DNE0876A, DNE0877A, DNE1080A, DNE1081A (02/28/2025), and DNE1147A, DNE1148A (03/31/2025). The product consists of 120 tablets per bottle and is identified by NDC 63304-175-13, manufactured by Sun Pharmaceutical Industries Limited in Dadra, India, and distributed by Sun Pharmaceutical Industries, Inc., in Cranbury, NJ.
Patients taking affected lots should contact their healthcare provider for guidance. Healthcare providers should verify their inventory against the affected lot numbers and notify patients if necessary.
The recalled product
- Product
- MESALAMINE (MESALAMINE)
- Brand
- MESALAMINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 10,690
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: DNE0875A Exp. 01/31/2025
- DNE0876A
- DNE0877A
- DNE1080A
- DNE1081A Exp. 02/28/2025
- DNE1147A
- DNE1148A Exp. 03/31/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same brand · MESALAMINE
- HighMesalamine extended-release capsules recalled due to dissolution failure
FDA (Drugs) · 2024-03-06
- ModerateTeva Recalls Mesalamine Tablets Due to Failed Dissolution Testing
FDA (Drugs) · 2020-11-18
- ModerateTeva Recalls Mesalamine Tablets Due to Dissolution Test Failures
FDA (Drugs) · 2020-03-11
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · microbial contamination
See all →- HighMedline IV Start Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Blood Culture Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09