Ibuprofen tablets recalled nationwide due to temperature abuse during manufacturing
McKesson Medical-Surgical is recalling Ibuprofen 400 mg prescription tablets nationwide due to temperature abuse during manufacturing. The manufacturing deviation may affect drug stability and efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a prescription medication with manufacturing deviations (temperature abuse) that could compromise drug stability and efficacy. Although no illnesses or injuries have been reported, this constitutes a risk-of-harm situation where compromised drug potency could affect patient health outcomes.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ibuprofen 400 mg prescription tablets in 100-count unit dose boxes distributed nationwide. The recall is due to cGMP deviations during manufacturing identified as temperature abuse.
Healthcare providers, pharmacies, and other facilities that received these products should consult the distribution dates included in the recall letter to determine if their inventory is affected. Patients currently taking ibuprofen from this batch should contact their healthcare provider if they have questions about their medication.
No illnesses or injuries have been reported related to this recall. Affected product should not be dispensed to patients. Consignees should return the product to the manufacturer or dispose of it according to FDA guidelines.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Ibuprofen
- Hazard
- temperature-abuse
- manufacturing-deviation
- reduced-potency
Distribution
Distributed nationwide across the United States.
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