Breckenridge Pharmaceutical: multiple capsules
Breckenridge recalls Duloxetine 30mg and 60mg capsules due to N-nitroso-duloxetine impurity above FDA limit.
Consumers should stop taking the recalled Duloxetine capsules and contact their healthcare provider for guidance. Return the product to the place of purchase for a refund or contact Breckenridge Pharmaceutical for further instructions.
Why it was recalled
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules, USP, 30 mg and 60 mg, due to the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit. The recall includes 30 mg capsules in 1000-count bottles and 60 mg capsules in 90-count and 1000-count bottles.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Duloxetine Delayed-Release Capsules, USP
| Lot code | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| 241074C, 2027 | 60 mg | NDC 51991-748-90 | D-0583-2026 |
| 241180C, 2027 | 30 mg | NDC 51991-747-10 | D-0582-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Impurity or Degradation recalls
Other recent recalls from Breckenridge Pharmaceutical, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification