The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0268-2024·Announced 2024-01-31

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 →

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