The Recall Desk
ModerateFDA (Drugs)·D-0537-2021·Announced 2021-06-02

Cardinal Health Recalls Benztropine Mesylate Tablets Due to Storage Temperature Excursions

Cardinal Health is recalling Benztropine Mesylate Tablets due to intermittent exposure to temperature excursions during storage. The affected products were distributed to 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 due to CGMP deviations involving temperature excursions, which is a low-risk contamination or process issue without reported injuries, fitting the Moderate severity criteria for minor labeling or low-risk contamination issues.

Plain-English summary

Cardinal Health Inc. is recalling Benztropine Mesylate Tablets, USP, in all pack sizes, styles, and strengths. These products were manufactured for Qualitest Pharmaceuticals in Huntsville, Alabama. The recall involves 60 bottles of the medication.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected products were distributed to Florida, Georgia, and South Carolina. The specific code for the recalled product is S2008031.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance on obtaining a replacement or alternative medication. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811
Manufacturer
Cardinal Health Inc.
Category
Drug — Tablets
Hazard
Affected units
60

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)

  • S2008031

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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