Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Breckenridge Pharmaceutical, Inc.
- Reason for Recall:
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Product Codes/Lot Numbers:
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0216-2026
Related Recalls
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.