Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Class II · Ongoing
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
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Affected lots / codes — check yours against this90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 172,263 bottles
- Distribution
- U.S. Nationwide
- Recall initiated
- October 9, 2025
- Classified
- October 24, 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-0100-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0100-2026%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 →