FDA recall, , Moderate risk
Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.
Summary by Recall Canary from the FDA notice
What happened
Breckenridge Pharmaceutical, Inc., of Berkeley Heights, New Jersey, began a recall on April 21, 2026, of Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, because the product contains N-nitroso-duloxetine impurity above the FDA recommended limit. The product was Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, and distributed nationwide in the USA.
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 the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Duloxetine Delayed-Release Capsules USP, 60mg
- NDC
- 51991-748-90
- Lot code
- 241069C
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- 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
- 98803
- Recall number
- D-0522-2026
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
