Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
This recall is currently active, issued September 17, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- August 8, 2025
- Posted
- September 17, 2025
- Recall Number
- D-0621-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,591 bottles
- Firm Location
- Berkeley Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Distribution
AZ, IN, NJ
Lot / Code Info
Lot 240927C, Exp 04/30/2027
More recalls by Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Tow...
Dec 10, 2025 · Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-co...
Nov 5, 2025 · Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by...
Aug 20, 2025 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026