Breckenridge Duloxetine 60mg capsules recalled for high impurity levels
Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules 60mg due to higher-than-acceptable levels of a chemical impurity called N-nitroso-duloxetine. This impurity was found during manufacturing quality checks. The recall affects about 360,000 bottles distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- Check if your Duloxetine 60mg matches one of the recalled lot numbers listed in the FDA notice.
- Do not stop taking your medication without talking to your doctor or pharmacist first.
- Contact your pharmacy or doctor to see if your supply is affected and discuss next steps.
- Return recalled bottles to your pharmacy for a replacement or refund.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 359,676 bottles
- Illnesses reported
- None reported
- Manufactured in
- 200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
- Classification
- Class II
- Recall number
- D-0583-2026
In the FDA's words
- Description
- Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. Distribution: Nationwide within the United States Affected quantity: 359,676 bottles
- Hazard
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
2 products in this recall
Breckenridge duloxetine capsules recalled for nitrosamine impurity
Breckenridge is recalling two sizes of duloxetine delayed-release capsules, 30 mg and 60 mg, made by Towa Pharmaceutical Europe in Spain. The recall covers about 374,400 bottles distributed nationwide. The capsules contain an impurity called N-nitroso-duloxetine at a level above the FDA's recommended interim limit. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), S…D-0582-2026 · 14,729 bottles.
- Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharma… (this page)D-0583-2026 · 359,676 bottles