Loperamide Hydrochloride Capsules Recalled Nationwide for Manufacturing Temperature Deviation
McKesson is recalling Loperamide Hydrochloride 2 mg capsules nationwide due to cGMP deviations involving temperature abuse during manufacturing that may affect medication stability.
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 3/5 (High).
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: This FDA Class II recall involves cGMP deviations with temperature abuse during manufacturing, which may compromise medication stability and efficacy. No illnesses or injuries have been reported; this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Loperamide Hydrochloride capsules, USP, 2 mg, in 100-count bottles (NDC 0378-2100-01), manufactured by Mylan Pharmaceuticals Inc. The product is distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations during manufacturing. The specific deviation involved temperature abuse, which may compromise the stability and quality of the medication.
Patients who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement supply or alternative medication. Healthcare providers should assess whether patients need immediate action based on individual medical circumstances.
McKesson is unable to identify the specific lot number received by individual customers. Affected customers have been notified with the distribution dates and the timeframe during which product may have been shipped to them.
The recalled product
- Product
- LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
- Brand
- LOPERAMIDE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Medication
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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