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.
What this means for you
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 (BETAMETHASONE DIPROPIONATE)
- Brand
- BETAMETHASONE DIPROPIONATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Corticosteroid
- Hazard
- temperature-abuse
- stability-concern
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)
- 0301680055466
- 0301680056159
Distribution
Distributed nationwide across the United States.
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