Cardinal Health Recalls Amantadine Hydrochloride Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 271 bottles of Amantadine Hydrochloride 100 mg tablets due to intermittent exposure to temperature excursions during storage.
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: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 271 bottles of Amantadine Hydrochloride Tablets 100 mg, 100-count bottles. The product is a prescription-only medication manufactured by Upsher-Smith Laboratories, Inc. in Maple Grove, MN, with NDC 0832-0111-00.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or healthcare provider for instructions on disposal or replacement. The specific lot code for the recalled product is 395310.
The recalled product
- Product
- AMANTADINE HYDROCHLORIDE (AMANTADINE HYDROCHLORIDE)
- Brand
- AMANTADINE HYDROCHLORIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 395310
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. 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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