CLASS III Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal) recalled
Novartis Consumer Health is recalling Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( . Tubes and 30 gm, distributed nationwide in the US. The recall was initiated on 19 Feb 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-576-2013
- FDA event ID
- 64372
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2013
- FDA classified
- 6 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Feb 2013 | Recall initiated by company | |
| 6 Jun 2013 | Classified by FDA | +107 days |
| 12 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
Where it was distributed
Nationwide and Puerto Rico, and Panama. Military distribution made.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Which lots are affected?
Lot #: 10109590, 10111050, Exp 2/28/13.
Where was it sold?
Nationwide and Puerto Rico, and Panama. Military distribution made.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 64372This product is part of a recall event; the main page for the event is Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream recalled | Novartis Consumer Health | Packaging Defects | Nationwide | |
| CLASS III | Novartis Lamisil AT Cream for Jock Itch recalled | Novartis Consumer Health | Packaging Defects | Nationwide | |
| CLASS III | Voltaren Gel (diclofenac sodium topical gel) recalled | Novartis Consumer Health | Packaging Defects | Nationwide | |
| CLASS III | Target Up & Up, athlete's foot cream recalled | Novartis Consumer Health | Other | Nationwide |
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