The Recall Desk
LowFDA (Drugs)·D-573-2013·Announced 2013-06-12

Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

Novartis is recalling Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible. The recall covers 12-gm and 30-gm tubes distributed nationwide, in Puerto Rico, and in Panama.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III and involves a packaging/labeling issue (illegible dates) with no reported illnesses or injuries, fitting the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal. The recall is due to a labeling issue where the lot and/or expiration date on the tube may not be legible. The affected products include 12-gm and 30-gm tubes with specific UPC and NDC codes.

The recall covers 818,064 12-gm tubes and 836,376 30-gm tubes. These products were distributed nationwide, in Puerto Rico, and in Panama, including military distribution. The source text does not report any illnesses or injuries associated with this recall.

Consumers should check their Lamisil AT Cream tubes against the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for a refund or replacement.

The recalled product

Product
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC c

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 (17)

  • (12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013
  • 10116816 31 May 2013
  • 10117695 31-Jul-2013
  • 10120283 31-Aug-2013
  • 10104980 28-Feb-2013
  • 10108711 31-Mar-2013
  • 10111313 30-Apr-2013
  • 10111509 30-Apr-2013
  • 10115506 30-Jun-2013
  • 10117696 30-Jun-2013
  • 10120763 31-Aug-2013
  • 10122695 30-Sep-2013
  • 10104983 28-Feb-2013
  • 10108714 31-Mar-2013
  • 10112072 30-Apr-2013
  • 10112073 30-Apr-2013 10113501 31-May-2013
  • 10122772 31-Aug-2013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →