The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0487-2018·Announced 2018-02-28

FDA Recalls Duloxetine HCl for Prescription Compounding Due to Stability Data Deficiencies

American Pharmaceutical Ingredients LLC is recalling Duloxetine HCl USP for prescription compounding due to a lack of stability data and controls to support expiration dates.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported, and the hazard is primarily related to manufacturing deviations (lack of stability data) rather than an active contamination or defect causing immediate harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Duloxetine HCl USP for prescription compounding, packaged in 100g and 1000g containers. The product is packed by American Pharmaceutical Ingredients, LLC, located in Waterford, Michigan, and is distributed nationwide within the United States. The specific lots affected are 061115-2 (NDC 58597-8632-6) and 061115-1 (NDC 58597-8632-8), both with an expiration date of May 31, 2019.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system. This classification is designated as FDA Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Healthcare professionals and pharmacies should stop using the affected lots of Duloxetine HCl USP and return them to the manufacturer or follow the specific instructions provided by American Pharmaceutical Ingredients, LLC. Consumers should not use this product, which is intended for prescription compounding only, and should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
10,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: a) 061115-2
  • Exp. 05/31/2019
  • b) 061115-1
  • Exp. 5/31/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 66 recalled by American Pharmaceutical Ingredients LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 66 products in this recall →

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