Recall Enforment Report D-0036-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 10-22-2024 for the product Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. The product was recalled due to failed impurities/degradation specification. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0036-202510-22-202411-13-2024Class II2,040 100-count bottlesMorphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.Failed Impurities/Degradation SpecificationOngoing
D-0037-202510-22-202411-13-2024Class II532 100-count bottlesMorphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.Failed Impurities/Degradation SpecificationOngoing