Lidocaine-Prilocaine Cream Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to CGMP deviations. The manufacturer went out of business and could not complete required stability studies to verify product integrity.
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: This is an FDA Class II recall due to CGMP deviations with no reported illnesses or injuries. The recall is driven by the firm's inability to complete stability studies, making it a precautionary, compliance-driven action rather than a response to documented harm.
Plain-English summary
Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and was unable to continue the stability studies required to verify that the product maintains its safety and effectiveness throughout its shelf life.
The affected product is a prescription cream available in 30-gram tubes, manufactured by HI-TECH PHARMACAL CO., INC. (Amityville, NY). All lot numbers were distributed nationwide in the USA and Puerto Rico.
Patients and healthcare providers should not use the recalled product. Anyone currently taking this medication should consult their healthcare provider or pharmacist about alternative treatment options.
The recalled product
- Product
- Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- cgmp-deviation
- stability-study-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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