Class I · High risk
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Chemical Contamination; presence of benzene.
Tinactin (Tolnaftate 1%)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Chemical Contamination: presence of benzene
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
Affected NDC
11523-0165-03
Compare with the code on your package — it is the most precise check available.
Drug: Tolnaftate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tinactin Tolnaftate NDC 11523-0165 |
10 mg/g | Aerosol, Spray Topical |
Bayer HealthCare LLC | OTC |
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- NDC code
- 11523-0165-3
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0251-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tolnaftate recalls
See all
Class II · Moderate risk
Blis-To-Sol Liquid
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I · High risk
Odor-Eaters Spray Powder
Chemical contamination: Presence of benzene
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
Other recalls by Bayer Healthcare Pharmaceuticals Inc.
All 2021 recalls
Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
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