Duloxetine Recall: Breckenridge 3,591 bottles
Announced 2026-06-17 · FDA
FDA is recalling Breckenridge Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, NDC 82009-030-10, Lot 240927C. The recall is due to CGMP deviations with an impurity, N-nitroso-duloxetine, above the proposed interim limit. Approximately 3,591 bottles were distributed to AZ, IN, NJ; the product was manufactured for Quallent Pharmaceuticals Health LLC in Grand Cayman and manufactured by Towa Pharmaceutical Europe, S.L. in Martorelles, Spain, with expiration date 04/30/2027.
| Brand | Breckenridge Pharmaceutical, Inc. |
|---|---|
| Product | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10 |
| Reason | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. |
| Severity | moderate |
| Units affected | 359676 |
| Distribution | AZ, IN, NJ |
| Agency | FDA |
| Recall / campaign no. | Lot 240927C, Exp 04/30/2027 |
WHAT YOU SHOULD DO
- Do not use recalled product.
- If you have affected bottles, contact the pharmacy or place of purchase to arrange return or disposal.
- If you have used this product and have concerns, talk to your healthcare provider and monitor for any adverse effects.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.