Mesalamine Delayed-Release Tablets recall
FDA recall D-0268-2024 · initiated Jan 18, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Mesalamine Delayed-Release Tablets in Jan 2024 — an FDA Class II recall (D-0268-2024) because CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,690 bottles
Details
- Product
- Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 18, 2024
- FDA report date
- Jan 31, 2024
Frequently asked
- Was Mesalamine Delayed-Release Tablets recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Mesalamine Delayed-Release Tablets in Jan 2024 — an FDA Class II recall (D-0268-2024) because CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Mesalamine Delayed-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0268-2024 was: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Is a recalled Mesalamine Delayed-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mesalamine Delayed-Release Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0268-2024.