Breckenridge Pharmaceutical recalls 30mg Duloxetine Delayed-Release Capsules with nitrosamine impurity above safety limits. Affected lots may cause serious health risks. Contact for return instructions.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical is recalling 30mg Duloxetine Delayed-Release Capsules bottles that contain a nitrosamine impurity above safety limits. This impurity could pose serious health risks to users.
The recalled capsules contain a nitrosamine impurity that exceeds the safety limit set by regulatory standards. Nitrosamines are known to be potentially harmful substances that could cause serious health issues when consumed in high amounts.
People who have the recalled 30mg Duloxetine Delayed-Release Capsules bottles (NDC# 51991-747-90 or 51991-747-10) from the manufacturer. Those with prescriptions for this medication are most at risk.
Check for bottles labeled 'Duloxetine Delayed-Release Capsules USP, 30 mg' with NDC numbers 51991-747-90 or 51991-747-10. The recall includes both 90-count and 1000-count bottles.
Identify the NDC number on the bottle to confirm if it's one of the recalled lots (51991-747-90 or 51991-747-10).
Reach out to Breckenridge Pharmaceutical for specific return or disposal instructions for the recalled product.
The recall indicates the product contains a nitrosamine impurity above safety limits, so it is not safe to use as recalled.
Check for bottles labeled 'Duloxetine Delayed-Release Capsules USP, 30 mg' with NDC numbers 51991-747-90 or 51991-747-10.
Contact Breckenridge Pharmaceutical directly for return or disposal instructions as the recall remedy is not specified in the record.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0388-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0388-2025 from Breckenridge. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
