Duloxetine Recall: Breckenridge 3,591 bottles
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot 240927C, Exp 04/30/2027 |
|---|---|
| Lot / date codes | 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other duloxetine recalls
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.