The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0170-2024·Announced 2024-01-03

Low-dose aspirin recall due to improper storage temperature conditions

Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a CGMP deviation involving exposure to improper storage temperatures. No illnesses, injuries, or hospitalizations are reported in the source. The hazard is theoretical—improper storage could affect drug stability and efficacy—but without documented adverse health effects, it meets the criteria for High severity.

Plain-English summary

Cardinal Healthcare is recalling Low Dose Aspirin 81 mg tablets (batch P126201) nationwide due to a Good Manufacturing Practice (CGMP) deviation. The products were exposed to temperatures outside of the labeled storage conditions, which could affect product stability and efficacy.

The affected product is a 120 tablet bottle of enteric-coated aspirin distributed by Rugby Laboratories. The batch number P126201 with NDC 0536-1234-41 has been identified as part of this recall. The recall is nationwide.

Consumers who have purchased this product should consult with a pharmacist or healthcare provider about the affected batch. Check your medication bottle for batch number P126201 and the recalled NDC number. Ask your pharmacist about proper disposal methods.

The recalled product

Product
ASPIRIN (ASPIRIN)
Brand
ASPIRIN
Manufacturer
CARDINAL HEALTHCARE
Category
Drug — OTC Medication
Hazard
Affected units
2

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)

  • Batch P126201

UPCs (1)

  • 0305361234416

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by CARDINAL HEALTHCARE 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 42 products in this recall →

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