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  5. FDA Recall: Duloxetine

FDA Recall Duloxetine

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The most recent Recall Enforcement Report that covers this product was initiated on March 5th, 2025 and classified as a Class II recall due to cgmp deviations: presence of n-nitroso-duloxetine impurity above recommended interim limit. This recall is currently ongoing, and the associated recall number is recall number is D-0277-2025. It pertains to Duloxetine identified by 57237-019.

Recall Number Recall Initiation Date Report Date Quantity Product Description Recall Reason Status
D-0277-202503-05-202503-26-20251223 bottlesDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.Ongoing
D-0188-202512-30-202401-15-202542,527 bottlesDuloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJCGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Ongoing
D-0189-202512-30-202401-15-202573,680 bottlesDuloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Ongoing
D-0190-202512-30-202401-15-2025244,460 bottlesDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJCGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Ongoing
D-0107-202511-19-202412-11-2024233,003 bottlesDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJCGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitOngoing
D-0106-202511-19-202412-11-2024122,925 bottlesDuloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJCGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitOngoing
D-0105-202511-19-202412-11-2024209,376 bottlesDuloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitOngoing

What is a Recall Enforcement Report?

A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.

When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.

The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.

Understanding Recall Reports

The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.

Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.

If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.