Quick Facts at a Glance
- Recall Date
- July 25, 2025
- Hazard Level
- HIGH
- Brand
- DULOXETINE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 2 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DULOXETINE
- Product type
- Duloxetine Delayed-Release Capsules
- Model numbers
- Lot 240539C, Exp 1/31/2027
- UPC codes
- 82009-029, 82009-030, 82009-032, 82009-031, 82009-029-05, 82009-030-10, 82009-032-10, 82009-031-30 +1 more
- Sizes
- 60 mg
- Sold at
- Unknown
- Where affected
- NJ, AZ
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 25, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Duloxetine delayed-release capsules are used to treat major depressive disorder, generalized anxiety disorder, and neuropathic pain. The product is manufactured in Spain for distribution in the US.
Why This Is Dangerous
N-nitroso-duloxetine impurity above FDA interim limit during CGMP evaluation could pose safety risks to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Immediate action is required to halt potential exposure to patients who may be taking the affected product.
Practical Guidance
How to identify if yours is affected
- Verify NDC 82009-032-10 on bottle label
- Check Lot 240539C and Exp 1/31/2027
- Confirm bottle contains 1,000 capsules per bottle and 60 mg strength
Where to find product info
FDA recall page for D-0580-2025; Breckenridge Pharmaceutical contact details in recall notice
What timeline to expect
Recall processing and replacement or refunds follow company communications; typical timelines range weeks to months
If the manufacturer is unresponsive
- Log all communications with the company
- File complaint with the FDA or state health department if unresponsive
- Consult healthcare provider for alternatives
How to prevent similar issues
- Verify drug stability and CGMP compliance before purchase
- Check NDC and lot numbers on every purchase
- Ask pharmacies about CGMP issues before dispensing
Documentation advice
Keep bottle packaging, receipts, and recall notices; document communications and any adverse reactions
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Product Details
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg. Quantity: 1,856 bottles. Manufacturer: Towa Pharmaceutical Europe, S.L., Martorelles, Spain. Importer/Distributor for US: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-032-10. Lot: 240539C. Expiration: 1/31/2027. Sold to: Distribution in New Jersey, Arizona, Indiana.
Reported Incidents
No specific patient injuries or adverse events are reported in the recall notice.
Key Facts
- Manufactured for Quallent Pharmaceuticals Health LLC
- Active recall as of 2025-07-25 with report date 2025-08-20
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Safety Guide
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