FDA Recalls Levetiracetam USP for Prescription Compounding Due to Stability Issues
American Pharmaceutical Ingredients LLC is recalling Levetiracetam 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 typically involves a reasonable probability of temporary or medically reversible health consequences. 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' criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Levetiracetam USP for prescription compounding, packaged in 500g and 1000g containers. The product is packed by American Pharmaceutical Ingredients, LLC, located in Waterford, Michigan, and was distributed nationwide within the United States.
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 specific container/closure system. This means the product may not remain stable or effective until the printed expiration date.
Affected lots include Lot 072616-1 (Expiration 06/29/2019) and Lot 060115-1 (Expiration 01/23/2018). The total quantity involved is 36,100 grams. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 36,100
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 (5)
- Lot #: a) 072616-1
- Exp. 06/29/2019
- b) 060115-1
- Exp. 01/23/2018
- 072616-1
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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