Amazon Basic Care Acetaminophen Tablet
FDA Recall NDC 72288-405
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 Amazon Basic Care Acetaminophen (NDC 72288-405). A significant event, classified as Class II, was initiated on May 22, 2025 by Amazon.com Services Llc. The reported reason for this action was: "cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
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
Class II Ongoing
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
May 22, 2025
Jun 25, 2025
4,608 bottles
Recall Profile & Regulatory Data
Event ID
96907
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Batch or Lot Expiration Information
Lot# : AEF124004A, Exp date 08/31/2026
Affected Packages Involved in this Recall
72288-405-10Product
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.
