Hydrocortisone Ointment Recalled Due to Temperature Exposure During Distribution
McKesson Medical-Surgical is recalling Hydrocortisone Ointment USP 2.5% nationwide due to temperature abuse during distribution that violated manufacturing standards.
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: FDA Class II recall with no reported illnesses or injuries. The deviation is a cGMP violation (temperature abuse) with unknown clinical impact. Without documented harm or specific risk-of-harm language in the source, this fits the rubric criterion for 'low-risk contamination, voluntary precautionary recalls.'
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Hydrocortisone Ointment USP 2.5% (1 oz tubes, NDC 0168-0146-30) manufactured by Sandoz Pharma and distributed nationwide.
The recall was initiated due to cGMP deviations involving temperature abuse during distribution. Temperature exposure can affect pharmaceutical product stability and quality.
The recalled product was distributed nationwide to healthcare facilities and pharmacies. McKesson is unable to identify specific lot numbers for individual consignees; each notification letter includes the distribution date and the timeframe during which affected product may have been shipped to that customer.
Consumers and healthcare providers should discontinue use of recalled Hydrocortisone Ointment and contact their pharmacy or healthcare provider for information about returns or alternative treatments.
The recalled product
- Product
- HYDROCORTISONE (HYDROCORTISONE)
- Brand
- HYDROCORTISONE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Corticosteroid
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0301680146300
- 0301680080314
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.
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