Lower riskDrug recall · FDA · Published May 22, 2025
Aurobindo Pharma Acetaminophen Tablets Recall: Brown Tablet Discoloration Risk
Aurobindo Pharma recalls 325mg acetaminophen tablets with brown surface discoloration due to manufacturing issues. Consumers should check NDC 72288-405-10 and lot number AEF124004A for affected products.
“Aurobindo Pharma Acetaminophen Tablets Recall: Brown Tablet Discoloration Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32057-aurobindo-pharma-acetaminophen-tablets-recall-brown-tablet-discoloration-risk. Based on FDA recall #D-0471-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2025%22&limit=1).
Aurobindo Pharma USA Inc voluntarily recalled Acetaminophen Tablets, 325 mg, 100-count bottles distributed by Amazon.com Services LLC on May 22, 2025, the FDA said. The recall addresses cGMP deviations resulting in tablet discoloration.
The FDA said the recall is due to confirmed consumer complaints observing tablet discoloration, specifically a brown surface on the tablets. These issues stem from cGMP deviations.
Context
GovInfoNow's records show Aurobindo Pharma USA Inc has 32 other recalls on record since April 9, 2013. Other recent recalls of similar products include a July 23, 2026 recall of Dicyclomine Capsules due to empty capsules and a Dec. 6, 2024 recall of Nebivolol Tablets for nitrosamine impurity risk. Additional recent actions involve an Aug. 3, 2026 recall of Sildenafil by Shoolin Pharma Chem and an Aug. 3, 2026 recall of Carbamazepine Tablets by Sun Pharmaceutical.
How to tell if you have this one
Check for brown discoloration on the surface of the tablets. Affected products have NDC 72288-405-10 and lot number AEF124004A, distributed through Amazon.com.
Brand
Aurobindo Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Tablet Discoloration
Inspect the tablets for brown discoloration on the surface.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0471-2025 (May 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0471-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.