CLASS II Drug recall · Reported 24 Nov 2021 · FDA Enforcement Report
Lotrimin AF (Miconazole nitrate 2%) Powder Spray recalled
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Miconazole nitrate 2%) Powder Spray, 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-0238-2022
- FDA event ID
- 88677
- Recalling firm
- Bayer Healthcare Pharmaceuticals, Whippany, NJ
- 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
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
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) CV017D9, EXP 10/31/2021; CV01940, EXP 11/30/2021; CV01CD9, EXP 4/30/2022; CV01D9T, CV01DZ3, EXP 6/30/2022; CV01EPP, EXP 7/31/2022; TN000TT, EXP 10/31/2022; TN003CG, EXP 1/31/2023; TN003CH, TN00407, EXP 3/31/2023; TN0041V, EXP 6/30/2023; TN0056W, EXP 7/31/2022; TN005P4, EXP 8/31/2022; TN006MJ, EXP 9/30/2022; (b) CV01940, CV01940A, EXP 11/30/2021; CV01AP2, EXP 02/28/2022; CV01D9T, CV01D9TA, CV01DZ3, EXP 06/30/2022; CV01EPP, EXP 07/31/2022; TN005P4, EXP 08/31/2022; TN000TT, TN000TTA, EXP 10/31/2022; TN003CG, EXP 01/31/2023; TN003CH, TN003CHA, TN00407, TN006TD, TN006TDB, TN00407A, EXP 03/31/2023; TN0041V, EXP 06/30/2023
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.
More recalls from Bayer Healthcare Pharmaceuticals
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vitrakvi (larotractenib) oral solution, 20mg/mL recalledVitrakvi | Bayer Healthcare Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Lotrimin AF, (Miconazole nitrate 2%), Powder Spray recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Tinactin (Tolnaftate 1%) Jock Itch Powder Spray Net WT133g recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Tinactin (Tolnaftate 1%) Powder Spray recalled by Bayer Healthcare | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |