Quick Facts at a Glance
- Recall Date
- November 24, 2025
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Quallent Pharmaceuticals Health, LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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, Quallent Pharmaceuticals Health, LLC
- Product type
- Duloxetine Delayed-Release Capsules
- Model numbers
- Lot #: 240947C, 240962C, Exp. Date 04/2027
- UPC codes
- 82009-029, 82009-030, 82009-032, 82009-031, 82009-029-05, 82009-030-10, 82009-032-10, 82009-031-30 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 24, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended 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
About This Product
Duloxetine Delayed-Release Capsules are prescribed for treating depression, anxiety, and certain types of pain. Patients value this medication for its effectiveness in managing chronic conditions.
Why This Is Dangerous
The presence of N-nitroso-duloxetine in the product raises cancer risk concerns, as this impurity exceeds FDA safety limits. Consumers using the affected capsules may face potential long-term health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who have purchased this product should stop use immediately to mitigate health risks. They may experience inconvenience in needing to find alternative medications.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for the lot numbers: 240947C or 240962C.
- Verify the expiration date, which should be April 2027.
- Confirm that the product is Duloxetine Delayed-Release Capsules, USP, 60 mg.
Where to find product info
Lot numbers and expiration dates are typically found on the label or the bottom of the bottle.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the company regarding the recall.
- Reach out to the FDA if the company does not respond.
How to prevent similar issues
- Always check for recent recalls before using a medication.
- Consult your healthcare provider about alternatives if a medication has been recalled.
- Look for FDA approval and recall history when purchasing medications.
Documentation advice
Keep receipts, communication records, and take photos of the product as evidence.
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Product Details
The recall involves Duloxetine Delayed-Release Capsules, USP, 60 mg, sold in 1,000-capsule bottles. The affected lot numbers are 240947C and 240962C with an expiration date of April 2027.
Key Facts
- Product: Duloxetine Delayed-Release Capsules, USP, 60 mg
- Quantity recalled: 3,397 bottles
- Manufactured by: Towa Pharmaceuticals Europe, S.L.
- Recall reason: N-nitroso-duloxetine impurity
- Classification: Class II
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Safety Guide
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