Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0506-2018·Announced 2018-02-28

Lidocaine HCl USP Recalled for Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding due to a lack of stability data supporting 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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a documentation and stability data issue rather than a confirmed contamination or acute injury risk.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding. The product is available in 100g, 500g, and 1000g packages and is distributed nationwide within the United States.

The recall was initiated because of 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 recall affects pharmacies and compounding facilities that purchased the affected lots. Consumers should not use the product and should contact their pharmacist or healthcare provider for guidance.

The recalled product

Product: Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: stability-data
expiration-date
Affected units: 166,000

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 (12)

Lot #: a) 021115-1
Exp. 01/15/2020
080415-1
Exp. 03/22/2020
b) 020116-2
Exp. 12/13/2020
021115-1
c) 020116-1
020116-2
exp. 01/15/2020
082416-1
082416-2 Exp. 01/31/2021.

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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Same hazard · stability data