CLASS II Drug recall · Reported 24 Nov 2021 · FDA Enforcement Report
Tinactin (Tolnaftate 1%) Liquid Spray Net WT150g, labeled as (a) recalled
Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Liquid Spray Net WT150g, labeled as (a), distributed nationwide in the US. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class II.
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-0243-2022
- FDA event ID
- 88677
- Recalling firm
- Bayer Healthcare Pharmaceuticals, Whippany, NJ
- Brand
- Tinactin
- Manufacturer
- Bayer HealthCare LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Benzene
Timeline
| 1 Oct 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +48 days |
| 24 Nov 2021 | 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
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Product as listed by the FDA
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 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.
Where it was distributed
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Questions about this recall
Why was it recalled?
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which lots are affected?
Lot # (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023; (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021; CV01980, CV019DS, EXP 12/31/2021; CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022; TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022
Where was it sold?
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
18 other products · FDA event 88677This product is part of a recall event; the main page for the event is Tinactin (Tolnaftate 1%) Powder Spray recalled by Bayer Healthcare.
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All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal recalled by BlistexBlistex | Blistex | Benzene | Nationwide |
| Drug | CLASS II | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalledLotrimin Daily Prevention Deo | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
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| Drug | CLASS II | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalledLotrimin Daily Prevention Deo | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalledLotrimin Daily Prevention Deo | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |