FDA Recalls Betamethasone Dipropionate Cream for Temperature-Abuse Storage Deviations
McKesson Medical-Surgical is recalling Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.
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 classification without reported illnesses, injuries, or safety hazards. The temperature-abuse deviation affects medication stability and efficacy, representing a precautionary recall with theoretical risk rather than acute harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Betamethasone Dipropionate Cream USP, 0.05%, in 45-gram tubes (NDC 0168-0055-46 and related package codes), manufactured by Sandoz Pharma. This is a prescription topical corticosteroid.
The recall stems from cGMP deviations involving temperature abuse. Exposure to improper temperatures may compromise the stability and potency of the medication.
The product was distributed nationwide. McKesson Medical-Surgical has notified customers who received shipments during the affected distribution period. Customers have been provided specific distribution dates in their recall letters.
Patients currently using this product should contact their healthcare provider or pharmacist for guidance. Report any adverse effects to the FDA's MedWatch program.
The recalled product
- Product
- Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Corticosteroid
- Affected units
- 1
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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