FDA recall, , Moderate risk
Breckenridge Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.
Summary by Recall Canary from the FDA notice
What happened
Breckenridge Pharmaceutical, Inc., of Berkeley Heights, New Jersey, recalled Duloxetine Delayed-Release Capsules, USP, in 60mg and 30mg strengths, because the product contains N-nitroso-duloxetine impurity above the FDA recommended interim limit. The recall began June 4, 2026, and was added to the FDA's Enforcement Report on June 8, 2026. The capsules were distributed nationwide within the United States, with 359,676 bottles of the 60mg strength and 14,729 bottles of the 30mg strength affected.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Duloxetine Delayed-Release Capsules, USP
- Strength
- 60 mg
- NDC
- 51991-748-90
- Lot code
- 241074C
- 240317
- 240318
- 240315C
- 240373C
- 240370C
- 240375C
- 240413C
- 240316
- 232311
- 240978C
- 241052C
- Strength
- 30 mg
- NDC
- 51991-747-10
- Lot code
- 241180C
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Breckenridge Pharmaceutical, Inc.Berkeley Heights, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99108
- Recall numbers
- D-0582-2026 to D-0583-2026
All recalls from Breckenridge Pharmaceutical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
