Aspirin Tablet
FDA Recall NDC 48433-129

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Aspirin (NDC 48433-129). A significant event, classified as Class II, was initiated on Nov 11, 2024 by Safecor Health, Llc. The reported reason for this action was: "cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

November 2024 Class II Recall: cGMP Deviations

Recall Number
Class II Ongoing
Reason for Recall
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Initiated
Nov 11, 2024
Reported
Nov 27, 2024
Quantity
1470 boxes

Recall Profile & Regulatory Data

Event ID
95659
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Safecor Health, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Batch or Lot Expiration Information
Lot# 24A0061, exp. date 05/23/2026
Affected Packages Involved in this Recall
48433-129-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.