Depo-Medrol injectable suspension recalled for manufacturing temperature control deviations
McKesson Medical-Surgical is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.
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 hazard is a cGMP deviation (temperature abuse during manufacturing) that could affect product quality and stability, but no specific adverse events are documented. This is a precautionary recall of a manufacturing defect.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension in 1 mL single-dose vials and 25-count boxes (NDC 0009-3475-01 and 0009-3475-03) due to deviations from current Good Manufacturing Practice standards. The recall involves 177 cartons distributed nationwide.
The reason for the recall is temperature abuse during manufacturing. Temperature control is critical for ensuring the stability, potency, and sterility of injectable medications. McKesson Medical-Surgical states it is unable to identify which specific lot numbers were received by individual customers; however, recall notification letters have been sent to affected healthcare facilities with specific distribution dates and the range of dates when impacted product may have been shipped.
No illnesses or injuries have been reported in connection with this product. Patients currently using Depo-Medrol should contact their healthcare provider with any questions about their treatment. Healthcare facilities that received this product should check their records, quarantine affected product, and follow instructions provided in recall notification letters from McKesson.
The recalled product
- Product
- DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
- Brand
- DEPO-MEDROL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Affected units
- 177
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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- Severe