Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Consumers and healthcare providers should stop using this product immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall involves Duloxetine Delayed-Release Capsules, USP, 60 mg, with 1,000 capsules per bottle. The product, NDC 82009-032-10, was manufactured in Spain and distributed in New Jersey, Arizona, and Indiana.
The recall stems from CGMP deviations, specifically the presence of N-nitroso-duloxetine impurity above FDA recommended interim limits. This impurity poses potential health risks.
As of now, there are no reported incidents or injuries associated with this recall. The recall is classified as Class II.
Stop using the product immediately. Consumers should contact Breckenridge Pharmaceutical, Inc. or their healthcare provider for further guidance.
For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0580-2025.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.