Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels
Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires minimum score of 4. No reported illnesses, injuries, or deaths in the source. Missing drug facts label is a serious hazard preventing access to critical safety information.
Plain-English summary
Aurohealth LLC is recalling Healthy Living branded Acetaminophen, Aspirin and Caffeine tablets (250 mg/250 mg/65 mg, in 100-count bottles) distributed through Aurobindo Pharma USA Inc because some bottles are missing the manufacturer's label containing drug facts information.
The recalled product, manufactured in India with NDC 58602-882-21, includes lot AC2523005A with expiration date 6/30/2025. Approximately 240 bottles were distributed in New Jersey, New York, and Pennsylvania.
The missing drug facts label prevents consumers from accessing ingredients, dosage information, warnings, and other important product details.
Consumers who have this product should not use it and should return it to the place of purchase, contact Aurohealth LLC, or speak with their pharmacist or healthcare provider.
The recalled product
- Product
- ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
- Brand
- ACETAMINOPHEN ASPIRIN AND CAFFEINE
- Manufacturer
- Aurobindo Pharma USA Inc
- Hazard
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: AC2523005A
- Exp 6/30/2025
Distribution
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