Diphenhydramine HCl oral solution recalled for temperature abuse during manufacturing
McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.
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: This is an FDA Class II recall for manufacturing deviations (temperature abuse) with no reported illnesses or injuries. The hazard is theoretical loss of product efficacy; without reported harm, the score does not exceed 3, warranting Moderate classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Diphenhydramine Hydrochloride oral solution, USP, 25 mg/10 mL, distributed in unit dose cups. The product was distributed nationwide to healthcare facilities.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. Temperature abuse can affect the stability and quality of pharmaceutical products.
McKesson Medical-Surgical states that it is unable to identify the specific lot numbers at this time. The company has notified affected customers with information about the dates their product may have been shipped.
Patients and healthcare providers who have this product should contact their pharmacist or healthcare provider for guidance on whether they have affected product and what steps to take.
The recalled product
- Product
- DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE)
- Brand
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Oral Solution
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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