Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported November 24, 2021
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Bayer Healthcare Pharmaceuticals Inc. recalled Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (… - a moderate-severity action.
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (… was recalled by Bayer Healthcare Pharmaceuticals Inc. in November 24, 2021. Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzen…. Check the official notice for the remedy. Verify recall #D-0241-2022 with the FDA Drug before acting.
The recall
Bayer Healthcare Pharmaceuticals Inc. issued this moderate-severity FDA Drug recall-cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzen….
- Moderate
- severity level
- Class II
- classification
- November 24, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0241-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0241-2022) was formally reported on November 24, 2021, with the manufacturer initiating the action on October 1, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Bayer Healthcare Pharmaceuticals Inc. is listed as the recalling firm, operating out of Whippany, NJ. Federal records list the affected scope as 1,801,332 cans.
The documented reason for this recall is: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Distribution data in the federal record shows the product reached: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,801,332 cans
Related Recalls
6
5 from same agency
Product description
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
Reason for recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0241-2022 |
| Date reported | November 24, 2021 |
| Date initiated | October 1, 2021 |
| Recalling firm | Bayer Healthcare Pharmaceuticals Inc. |
| Firm location | Whippany, NJ |
| Affected scope | 1,801,332 cans |
| Distribution | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0241-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 1,801,332 cans.
Why was this product recalled? ▼
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0241-2022.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0241-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 24, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.