Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,
Akorn recalls Lidocaine 2.5% and Prilocaine 2. 5% 30g tubes (Rx only) due to stability testing finding an unknown impurity that may degrade the product.
Lower-risk recall
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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What happened, in plain English
Akorn is recalling Lidocaine 2.5% and Prilocaine 2.5% 30g tubes (prescription only) because routine stability testing found an unknown impurity that could degrade the product. This may pose a risk to users if the product degrades over time. Read more at govinfonow.com/recall/39832-akorn-lidocaine-2-5-cream-recall-impurity-risk-in-30g.
Source Summary by GovInfoNow · govinfonow.com/recall/39832-akorn-lidocaine-2-5-cream-recall-impurity-risk-in-30g · Updated October 6, 2026 · FDA enforcement record: FDA #D-1046-2018
Cite this page
“Akorn Lidocaine 2.5% Cream Recall: Impurity Risk in 30g Tubes.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39832-akorn-lidocaine-2-5-cream-recall-impurity-risk-in-30g. Based on FDA recall #D-1046-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2018%22&limit=1).
Why it’s dangerous
Routine stability testing found an unknown impurity in the product that could degrade over time. This degradation might affect the product's safety and effectiveness, but the risk is not described as causing serious injury.
Who’s affected
Prescription users of Lidocaine 2.5% and Prilocaine 2.5% 30g tubes (NDC 50383-667-30, Lot 356309, expiring 3/2019) are affected. People using these products for medical purposes are most at risk.
How to tell if you have this one
Check for the 30g tube labeled 'Lidocaine 2.5%' or 'Prilocaine 2.5%' with NDC 50383-667-30 and Lot 356309. The product expires March 2019.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Verify the product's NDC number (50383-667-30) and lot number (356309) to confirm it is part of the recall.
Questions people ask
Is this product safe to use?
The recall states that an unknown impurity was found during stability testing, but it does not specify that the product is unsafe for use. The risk is described as low.
What should I do if I have this product?
The recall does not provide specific action steps for users. You should check the product details to confirm if it is part of the recall.
How can I confirm if my product is recalled?
Check for the NDC number 50383-667-30 and lot number 356309 on the product label. The product expires March 2019.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1046-2018 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1046-2018 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1046-2018 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1046-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.