Overview
- Aurobindo Pharma USA initiated a voluntary nationwide recall of 112,932 bottles of Amazon Basic Care Extra Strength Acetaminophen 500 mg on Sept. 18 after consumers reported discolored caplets.
- The recall covers 200-, 500- and 1,000‑count bottles across specific lot numbers with expiration dates from Sept. 30, 2027, to Feb. 29, 2028 and affects roughly 14,640 200‑count, 90,456 500‑count and 7,836 1,000‑count bottles.
- Amazon says it is coordinating with the manufacturer and the FDA, has contacted affected customers about refunds, and directs buyers to check order histories and lot numbers on its site.
- No illnesses or adverse health effects have been formally reported so far and the FDA has logged the enforcement report but has not yet classified the recall’s health risk.
- The incident follows a smaller discoloration recall by the same maker in May 2025 and raises questions about quality controls for private‑label drugs made abroad, with the FDA classification and any further inspections the key items to watch next.