Quick Facts at a Glance
- Recall Date
- August 8, 2025
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Quallent Pharmaceuticals Health, Towa Pharmaceutical Europe
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 2 states
- At-Risk Groups
- GENERAL, PREGNANT
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, Quallent Pharmaceuticals Health, Towa Pharmaceutical Europe
- Product type
- Duloxetine Delayed-Release Capsules
- Model numbers
- Lot 240927C, Exp 04/30/2027
- 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
- 1000 capsules/bottle
- Sold at
- Unknown
- Where affected
- AZ, NJ
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 8, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP deviations: N-nitroso-duloxetine impurity above the proposed 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 prescribed antidepressant medications used for treating major depressive disorder, generalized anxiety disorder, and other conditions.
Why This Is Dangerous
Manufacturing deviations led to a potentially harmful impurity, N-nitroso-duloxetine, above interim limits, which may pose health risks with prolonged exposure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall affects 3,591 bottles distributed to three states, with guidance to stop use immediately and seek medical guidance.
Practical Guidance
How to identify if yours is affected
- Check NDC 82009-030-10 on the bottle.
- Inspect Lot 240927C.
- Verify expiration date 04/30/2027.
Where to find product info
FDA recall page for enforcement report D-0621-2025.
What timeline to expect
Recall remedies typically processed within weeks to months; expect notices by Breckenridge through official channels.
If the manufacturer is unresponsive
- Escalate to FDA Consumer Complaint Hotline
- File a report with state attorney general if needed
How to prevent similar issues
- Ensure manufacturers follow CGMP, verify NDC codes before dispensing
- Consult prescriber about alternatives if stopping medication
- Stay updated with FDA recall notices
Documentation advice
Keep recall notices, bottle labels, lot numbers, and correspondence with Breckenridge for refunds or replacements
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Product Details
Product: Duloxetine Delayed-Release Capsules, USP, 30 mg. Bottle size: 1,000 capsules. Rx Only. NDC: 82009-030-10. Manufacturer: Towa Pharmaceutical Europe S.L., Martorelles ( Barcelona ), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. Quantity: 3,591 bottles. Lot: 240927C. Expiration: 04/30/2027. Distributed to: AZ, IN, NJ.
Reported Incidents
No specific injuries or incidents are described in the recall notice.
Key Facts
- Distributed to AZ, IN, NJ
- Manufacturer: Towa Pharmaceutical Europe S.L. (Spain) for Quallent Pharmaceuticals Health LLC
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Safety Guide
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