Breckenridge Duloxetine 30mg capsules recalled for N-nitroso impurity above FDA limit
Breckenridge Pharmaceutical is recalling one lot of Duloxetine Delayed-Release Capsules 30mg due to the presence of N-nitroso-duloxetine impurity above FDA's recommended interim limit. This is a manufacturing quality issue. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have lot 241180C with expiration date April 2027.
- Contact your pharmacist or doctor before stopping this medication.
- Your pharmacist can help you obtain a replacement prescription.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 14,729 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-0582-2026
In the FDA's words
- 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 CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Lot: 241180C, Exp. Date April 2027. Distribution: Nationwide within the United States Affected quantity: 14,729 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… (this page)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…D-0583-2026 · 359,676 bottles