Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Reported: July 16, 2025 Initiated: June 30, 2025 #D-0511-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc.
- Units Affected
- 12,242 30-count bottles
- Distribution
- U.S. Nationwide
- Location
- Berkeley Heights, NJ
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.. Recalled by Breckenridge Pharmaceutical, Inc.. Units affected: 12,242 30-count bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 16, 2025. Severity: Moderate. Recall number: D-0511-2025.
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