Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Class II · Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Affected lots / codes — check yours against thisLot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 7389 bottles
- Distribution
- Nationwide within the United States
- Recall initiated
- November 24, 2025
- Classified
- December 3, 2025
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0216-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0216-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →