Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech
Akorn recalls 2% Lidocaine Hydrochloride Oral Topical Solution (viscous) due to failed viscosity specification. This may cause improper application. Contact Akorn for details.
Lower-risk recall
Failed viscosity specification - product was below specificcation
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling 2% Lidocaine Hydrochloride Oral Topical Solution (viscous) because it failed viscosity specifications. This could lead to improper application and potential misuse. Read more at govinfonow.com/recall/34830-akorn-lidocaine-2-oral-topical-solution-recall-failed-viscosity-specification.
Source Summary by GovInfoNow · govinfonow.com/recall/34830-akorn-lidocaine-2-oral-topical-solution-recall-failed-viscosity-specification · Updated September 23, 2026 · FDA enforcement record: FDA #D-0846-2022
Cite this page
“Akorn Lidocaine 2% Oral Topical Solution Recall: Failed Viscosity Specification.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34830-akorn-lidocaine-2-oral-topical-solution-recall-failed-viscosity-specification. Based on FDA recall #D-0846-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0846-2022%22&limit=1).
Why it’s dangerous
The product failed viscosity specifications, meaning it was too thin. This could cause the solution to flow too easily, making it difficult to apply correctly and potentially leading to improper use.
Who’s affected
Prescription users of this lidocaine topical solution who received the specific lot number (370978) from Hi-Tech Pharmacal Co., Inc. in Amityville, NY. Patients using the product for pain relief may be at risk if the solution does not apply properly.
How to tell if you have this one
Check for the product name 'Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%', 100 mL bottles, manufactured by Hi-Tech Pharmacal Co., Inc. in Amityville, NY, with lot number 370978 and expiration date 9/30/2022.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, lot number, and expiration date to confirm if it matches the recalled items.
Questions people ask
Is this product safe to use?
The product was recalled due to failed viscosity specifications, which may affect proper application. It is not recommended for use until the recall is addressed.
How can I get a replacement?
The recall record does not specify a replacement option or remedy.
What should I do if I have this product?
The recall record does not provide specific instructions for action beyond checking product details.
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-0846-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0846-2022 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-0846-2022 (April 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0846-2022 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.