The Recall Desk
ModerateFDA (Drugs)·D-0418-2021·Announced 2021-06-02

Cardinal Health Recalls Namzaric Due to Temperature Excursions

Cardinal Health is recalling 659 bottles of Namzaric capsules due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

What this means for you

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 reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation (temperature excursion) rather than a confirmed contamination or defect causing immediate severe harm, fitting the Moderate category for low-risk contamination or precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 659 bottles of Namzaric (memantine hydrochloride and donepezil hydrochloride) capsules, 14 mg/10 mg, 30-count bottles. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by lot code W04815 and NDC 0456-1214-30. The recall covers distribution in Florida, Georgia, and South Carolina. Namzaric is a prescription medication used to treat moderate to severe Alzheimer's disease.

Consumers and healthcare providers should check their inventory for the specific lot code and NDC listed above. If the product is found, it should be stopped from use and returned to the pharmacy or distributor for credit. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled product.

The recalled product

Product
NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE)
Brand
NAMZARIC
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
659

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)

  • W04815

UPCs (2)

  • 0304561221301
  • 0304561207305

Distribution

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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