The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0497-2021·Announced 2021-06-02

Cardinal Health Recalls Tylenol Acetaminophen Liquid Gels Due to Temperature Excursions

Cardinal Health Inc. is recalling 37 bottles of Tylenol Acetaminophen Liquid Gels because of intermittent temperature exposure 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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 37 bottles of Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer, 20 Liquid Gels 325 mg each (NDC 50580-487-20). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. All lots were distributed between February 23, 2021, and March 10, 2021.

Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.

The recalled product

Product
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20
Manufacturer
Cardinal Health Inc.
Category
Drug — Over-the-Counter Pain Reliever
Hazard
Affected units
37

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)

  • All Lots distributed 02/23/2021 through 03/10/2021.

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 →

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