← FDA ENFORCEMENT
D-0641-2024Class I

Aurobindo Pharma USA Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Aurobindo Pharma USA Inc
Product type
Drug
Status
Ongoing
Report date
2024-08-28
Distribution
NJ, NY & PA
Firm state
NJ
Product quantity
240 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

Healthy 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.

Code / lot info

Lot#: AC2523005A, Exp 6/30/2025

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →