Quick Facts at a Glance
- Recall Date
- June 4, 2026
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Breckenridge Pharmaceutical, Inc.
- Geographic Scope
- 1 states
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.
- Model numbers
- Lot: 241180C, Exp. Date April 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
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 4, 2026
Reported by FDA DRUG
June 17, 2026
RecallRadar source check
June 23, 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
Get instant alerts for DULOXETINE recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10. Generic: DULOXETINE HYDROCHLORIDE; Brand: DULOXETINE. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Classification: Class II. Quantity: 14,729 bottles.. Distribution: Nationwide within the United States
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.