Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

FDA recall notice · announced January 1, 2025 · Remedyrepack

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Notes

Distribution: Nationwide in the US
Lot/code information: a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
Quantity: a) 1,564 cards, b) 799 bottles
Status: Ongoing
Products in this recall event:
- Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allenda (D-0165-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.