Drug FDA Class II Ongoing cGMP deviation
Duloxetine 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.
Breckenridge Pharmaceutical, Inc. Published Dec 10, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Breckenridge Pharmaceutical, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Hazards
N-nitroso-duloxetine · primary
Affected products (1)
Duloxetine 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.
DULOXETINE · 3397 bottles
NDC: 82009-029, 82009-030, 82009-032, 82009-031, 82009-029-05, 82009-030-10, 82009-032-10, 82009-031-30, 82009-031-90
Code info: Lot #: 240947C, 240962C, Exp. Date 04/2027
Affected areas
Nationwide
Timeline
- InitiatedNov 24, 2025
- PublishedDec 10, 2025
- Recall number
- D-0215-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.