Overview
- Aurobindo Pharma USA initiated a voluntary nationwide recall that covers 112,932 bottles of Amazon Basic Care Extra Strength Acetaminophen 500 mg caplets.
- The recall was prompted by consumer reports of visibly discolored tablets and covers specific lot numbers across 200-, 500- and 1,000-count bottles.
- Aurobindo issued the recall on Sept. 18, and Amazon confirmed it is coordinating with the manufacturer and the FDA while notifying affected customers about returns and refunds.
- The FDA has logged the enforcement report but has not assigned a recall classification or identified confirmed health risks, and no adverse events linked to these lots have been reported publicly.
- This episode follows a May 2025 Aurobindo-produced Amazon acetaminophen recall and raises questions about quality assurance and traceability for outsourced private‑label drugs sold through e-commerce platforms.