FDA Recall D-0165-2025

RemedyRepack Inc. · Indiana, PA

Class II Ongoing 528 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Reason for recall

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

Recall record

Recall number: D-0165-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2024-12-02
Classified by FDA Center: 2024-12-26
FDA published: 2025-01-01
Recalling firm: RemedyRepack Inc.
Firm location: Indiana, PA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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