Quick Facts at a Glance
- Recall Date
- November 24, 2025
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Breckenridge Pharmaceutical, Inc.
- 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, Breckenridge Pharmaceutical, Inc.
- Product type
- Duloxetine Delayed-Release Capsules
- Model numbers
- Lot #: 240534C, Exp. Date 01/2027, 240977C, Exp. Date 04/2027.
- UPC codes
- 51991-746, 51991-747, 51991-748, 51991-750, 51991-746-06, 51991-746-90, 51991-746-05, 51991-747-33 +6 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 a prescription medication used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. Patients buy this medication to manage chronic pain and mood disorders.
Why This Is Dangerous
The presence of N-nitroso-duloxetine above FDA limits raises concerns about potential carcinogenic effects, making the product unsafe for consumption.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers are urged to stop using the product immediately to avoid potential health risks. This recall can cause inconvenience for those relying on Duloxetine for treatment.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your capsule bottle.
- Verify the expiration date.
- Identify if your bottle matches Lot #: 240534C or 240977C.
Where to find product info
The lot number and expiration date are typically found on the label of the bottle.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with Breckenridge Pharmaceutical, Inc. if they do not respond promptly.
- Document all communications and consider filing a complaint with the FDA.
How to prevent similar issues
- Look for FDA approval and certifications when purchasing medications.
- Be cautious of product recalls and check for updates regularly.
- Consult with healthcare providers about alternative medications.
Documentation advice
Keep receipts, correspondence, and any documentation related to the recall for your records.
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Product Details
The recall involves Duloxetine Delayed-Release Capsules, USP, 60 mg, sold in 1000-capsule bottles. The affected lot numbers include 240534C with an expiration date of January 2027 and 240977C with an expiration date of April 2027. These products were distributed nationwide in the United States.
Key Facts
- Manufactured by Towa Pharmaceuticals Europe, S.L.
- Distributed by Breckenridge Pharmaceutical, Inc.
- N-nitroso-duloxetine impurity above FDA limits
- Stop use immediately
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Safety Guide
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