Cardinal Health Recalls Miconazole 7 Cream Due to Temperature Excursions
Cardinal Health Inc. is recalling 71 tubes of Miconazole 7 2% cream due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a storage condition deviation (temperature excursion) without reported harm, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate score.
Plain-English summary
Cardinal Health Inc. is recalling 71 tubes of Miconazole 7 2% 45GM APL cream (NDC/UPC 009047734459). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed to Florida, Georgia, and South Carolina. All lots were distributed between February 23, 2021, and March 10, 2021.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Topical Antifungal
- Affected units
- 71
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Similar recalls
- ModerateChlorthalidone Tablets Recalled for Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- HighDrug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
FDA (Drugs) · 2024-01-03
- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateKetoconazole Cream 2% Recalled Due to Manufacturing Temperature Abuse
FDA (Drugs) · 2022-06-15
- ModeratePrescription Aripiprazole tablets recalled nationwide for storage temperature deviation
FDA (Drugs) · 2024-01-03
- ModerateTerconazole Vaginal Suppositories Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03