FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned 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 typically indicates a temporary or medically reversible adverse health consequence. The hazard is a documentation and stability data gap rather than a confirmed contamination or acute injury risk, aligning with the 'Moderate' severity criteria for minor labeling or documentation issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Tretinoin USP for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The affected product is available in 5g, 10g, and 25g packages and is distributed nationwide within the United States. The recall involves specific lot numbers with expiration dates ranging from April 2018 to June 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 retest or expiration dates assigned to the product in its container/closure system. This deficiency means the product's stability over time has not been adequately verified.
Healthcare professionals and pharmacies are advised to stop using the affected lots and return them to the manufacturer. Consumers who have purchased this product should consult their healthcare provider or pharmacist for guidance on whether to continue using it or seek a replacement.
The recalled product
- Product
- Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Prescription Compounding
- Affected units
- 2,100
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 (9)
- Lot #: a) 062615-1
- Exp. 06/09/2018
- 071816-1
- exp. 06/05/2019
- b) 043015-1
- Exp. 04/01/2018
- 062615-1
- c) 062615-1
- Exp. 06/05/2019.
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.
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