Lidocaine USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine USP for prescription compounding because the manufacturer lacks stability data 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 reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute injury risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Lidocaine USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States. The recall involves specific lots with expiration dates of 09/30/2020 and 05/31/2021.
The recall was initiated 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.
This product is for prescription use only. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), 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
- 74,000
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 (8)
- Lots #: a) 110215-2
- Exp. 09/30/2020
- b) 110215-1
- 082516-1
- Exp. 05/31/2021
- c) 110215-1
- d) 110215-1
- Exp. 05/31/2021.
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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