FDA Recalls Itraconazole USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Itraconazole USP for prescription compounding because it lacks stability data to support its expiration dates.
What this means for you
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 is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a lack of stability data, which is a quality control issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or quality errors without reported illness.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Itraconazole USP (Micronized) for prescription compounding, packed by American Pharmaceutical Ingredients LLC. The product is available in 10g, 25g, 100g, and 1000g packages and is distributed nationwide within the United States.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the stability data and controls necessary to support the assigned retest or expiration dates for the product in its current container/closure system.
Healthcare professionals and patients should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions. The affected lots include specific expiration dates ranging from April 30, 2020, to July 31, 2021, as detailed in the recall notice.
The recalled product
- Product
- Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 483
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 52,000
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 (14)
- Lot #: a) 061515-1
- Exp. 04/30/2020
- b) 080316-1
- Exp. 06/30/2021
- 052317C-1
- Exp 02/28/2022
- 061515-1
- c) 061515-1
- 080316-1
- 091216-1
- Exp. 07/31/2021
- d) 061515-1
- 061515-2
- exp. 04/30/2020
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.
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