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
- microbial-contamination
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.
Related recalls
Same brand · MESALAMINE
- HighMesalamine extended-release capsules recalled due to dissolution failure
FDA (Drugs) · 2024-03-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27