Lower riskDrug recall · FDA · Published May 22, 2023
Aurobindo Pharma recalls acetaminophen caplets due to impurity discoloration
Aurobindo Pharma USA Inc. recalls 500mg acetaminophen caplets with discoloration issues. Products may contain impurities affecting safety. Consumers should check lot numbers and contact the company for details.
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Take action
Contact the company
📍Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
“Aurobindo Pharma recalls acetaminophen caplets due to impurity discoloration.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33431-aurobindo-pharma-recalls-acetaminophen-caplets-due-to-impurity-discoloration. Based on FDA recall #D-0765-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2023%22&limit=1).
Aurobindo Pharma USA Inc. recalled Pain Reliever, Acetaminophen USP Caplets due to failed impurity specifications causing discoloration, the FDA said on May 22, 2023.
The FDA said the product was out of specification for an impurity after a firm investigation into customer complaints regarding discoloration found the cause. The recall is classified as Class II.
Context
GovInfoNow's records show Aurobindo Pharma USA Inc has 32 other recalls on record since April 9, 2013. Recent brand recalls include a July 23, 2026 recall of Dicyclomine Capsules due to empty capsules and a May 22, 2025 recall of Acetaminophen Tablets for brown tablet discoloration risk. Other recent recalls of similar products include Sun Pharmaceutical's December 30, 2025 Fluocinolone Acetonide Solution Recall for impurity risk and Ajanta Pharma's April 29, 2026 Duloxetine Capsules recall due to nitrosamine impurity risk.
How to tell if you have this one
Check for the lot numbers P2200101, P2200178, or P2200230 on the product packaging. The product is a 225-count bottle of 500mg acetaminophen caplets sold by Walgreen Co.
Brand
Aurobindo Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot numbers P2200101, P2200178, or P2200230 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 9 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-0765-2023 (May 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0765-2023 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.