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Recall Enforment Report D-0216-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Breckenridge Pharmaceutical, Inc., originally initiated on 11-24-2025 for the product 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. The product was recalled due to cgmp deviations; presence of n-nitroso-duloxetine impurity above the fda recommended limit. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0216-202611-24-202512-10-2025Class II7389 bottlesDuloxetine 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.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitOngoing
D-0215-202611-24-202512-10-2025Class II3397 bottlesDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
51991-746Duloxetine Delayed-ReleaseDuloxetine HydrochlorideCapsule, Delayed Release PelletsOralBreckenridge Pharmaceutical, Inc.Human Prescription Drug
51991-747Duloxetine Delayed-ReleaseDuloxetine HydrochlorideCapsule, Delayed Release PelletsOralBreckenridge Pharmaceutical, Inc.Human Prescription Drug
51991-748Duloxetine Delayed-ReleaseDuloxetine HydrochlorideCapsule, Delayed Release PelletsOralBreckenridge Pharmaceutical, Inc.Human Prescription Drug
51991-750Duloxetine Delayed-ReleaseDuloxetine HydrochlorideCapsule, Delayed Release PelletsOralBreckenridge Pharmaceutical, Inc.Human Prescription Drug
82009-029Duloxetine Duloxetine HydrochlorideCapsule, Delayed Release PelletsOralQuallent Pharmaceuticals Health, LlcHuman Prescription Drug
82009-030Duloxetine Duloxetine HydrochlorideCapsule, Delayed Release PelletsOralQuallent Pharmaceuticals Health, LlcHuman Prescription Drug
82009-031Duloxetine Duloxetine HydrochlorideCapsule, Delayed Release PelletsOralQuallent Pharmaceuticals Health, LlcHuman Prescription Drug
82009-032Duloxetine Duloxetine HydrochlorideCapsule, Delayed Release PelletsOralQuallent Pharmaceuticals Health, LlcHuman Prescription Drug