Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing compliance deviations; no reported illnesses or injuries documented. Rated High because the inability to complete stability testing creates a risk-of-harm scenario without documented adverse events.
Plain-English summary
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes distributed nationwide in the United States and Puerto Rico. This is a prescription-only product. The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility.
The firm went out of business and was unable to complete the stability studies required by federal regulations. These studies ensure that a drug maintains its quality, strength, and safety throughout its shelf life. Without completion of this testing, the long-term stability and safety profile of the product cannot be verified.
Affected consumers should not use this product and should consult their healthcare provider about alternative medications.
The recalled product
- Product
- Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical / Jelly
- Hazard
- cgmp-violation
- stability-testing-incomplete
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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