Breckenridge Pharmaceutical: multiple capsules
Breckenridge recalls Duloxetine capsules over N-nitroso-duloxetine impurity above FDA limit.
Check your prescription bottle for NDC 51991-747-10 (30mg, 1000-count) or other affected lots. Stop using the capsules and return them to the pharmacy for a refund or replacement. Contact Breckenridge Pharmaceutical at 1-800-XXX-XXXX for further instructions.
Why it was recalled
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules, USP, 30mg and 60mg, due to the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit, which may increase the risk of cancer.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Recall # |
|---|---|
| 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. | D-0583-2026 |
| 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 | D-0582-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Breckenridge Pharmaceutical, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification