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Class I · Most seriousActive recall

Acetaminophen Aspirin And Caffeine

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot#: AC2523005A, Exp 6/30/2025
Where it was soldNJ, NY & PA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameACETAMINOPHEN ASPIRIN AND CAFFEINE
Generic nameACETAMINOPHEN, ASPIRIN AND CAFFEINE
Active ingredient(s)ACETAMINOPHEN, ASPIRIN, CAFFEINE
Distributed by / forAurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ
NDC58602-882-21
Show the full FDA record
Full product labelHealthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
Recalling firmAurobindo Pharma USA Inc
DistributionNJ, NY & PA
Quantity240 bottles
Recall initiated2024-07-11
Report date2024-08-28
Recall completed—
Recall numberD-0641-2024
ClassificationClass I
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.