FDA Recalls Mupirocin Ointment Due to Temperature Control Deviations
Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. While temperature abuse during distribution could compromise drug quality and efficacy, no actual harm has been documented, making this a precautionary quality control recall.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Mupirocin Ointment, USP 2% (NDC 0093-1010-42), a topical prescription antibiotic supplied in 22-gram tubes. The product was manufactured by Teva Pharmaceuticals USA, Inc.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during distribution. Improper temperature control during storage and shipment may compromise the product's quality and efficacy.
The affected product was distributed nationwide to healthcare facilities and pharmacies. Because lot numbers cannot be specifically identified for individual consignees, customers should review distribution dates provided in individual recall notifications.
Consumers and healthcare providers who have received potentially affected Mupirocin Ointment should contact their pharmacy or healthcare provider. The product should not be used if there is uncertainty about whether it was stored under proper temperature conditions.
The recalled product
- Product
- MUPIROCIN (MUPIROCIN)
- Brand
- MUPIROCIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Antibiotic
- Affected units
- 5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
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