FDAClass IIIMay 11, 2022

Lidocaine Hydrochloride Oral Topical Solution recall

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville…

Why was Lidocaine Hydrochloride Oral Topical Solution recalled?

Failed viscosity specification - product was below specificcation

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 370978, Exp 9/30/2022

Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville…
Recalling firm
Akorn, Inc.
Quantity
66,744 bottles
Distribution
Nationwide USA and Puerto Rico
Recall date
May 11, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls