Lidocaine Oral Topical Solution Recalled Due to Failed Viscosity Specification
Akorn, Inc. is recalling 66,744 bottles of Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Lot #370978) nationwide because the product's viscosity was below the required specification.
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: FDA Class III recalls are typically scored 1–2. No illnesses or injuries have been reported in connection with this product. The hazard is a manufacturing specification failure without documented patient harm, resulting in a Moderate (2) score.
Plain-English summary
Akorn, Inc. is recalling Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, supplied in 100 mL bottles (NDC 50383-775-04). The recalled lot (Lot #370978, expiration 9/30/2022) was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the product failed to meet viscosity specifications during quality control testing. The product's viscosity was below the required specification for this oral topical solution.
Patients and healthcare providers who have the recalled product should not use it. The product should be discontinued and properly disposed of according to local regulations. Consumers should contact their pharmacy or healthcare provider if they have questions about this recall.
The recalled product
- Product
- Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
- Manufacturer
- Akorn, Inc.
- Category
- Drug
- Hazard
- viscosity-failure
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 (2)
- Lot #: 370978
- Exp 9/30/2022
Distribution
Distributed nationwide across the United States.
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