FDA Recalls Prazosin Hydrochloride Capsules Due to Temperature Storage Deviations
McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage 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 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 a Class II FDA recall due to manufacturing process deviations (temperature abuse). No illnesses or injuries are mentioned in the recall notice, and the hazard is precautionary rather than based on confirmed product defect or harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Prazosin Hydrochloride Capsules, USP, 1 mg (Rx only) distributed nationwide due to temperature deviations that occurred during storage or transit. The temperature control deviations represent a deviation from current good manufacturing practice (cGMP) standards.
Temperature deviations during storage or handling may affect the stability and integrity of the medication. The affected product includes 100-count bottles with NDC code 0378-1101-01, manufactured by Mylan Pharmaceuticals Inc.
Patients who have received this medication should consult with their pharmacy or healthcare provider regarding whether their medication was affected by this recall.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription
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.
See all 130 products in this recall →Related recalls
Same brand · PRAZOSIN HYDROCHLORIDE
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