CLASS I ONGOING Drug recall · Reported 28 Aug 2024 · FDA Enforcement Report
Healthy Living Acetaminophen, Aspirin (Nsaid) and Caffeine recalled
Aurobindo Pharma USA is recalling Healthy Living Acetaminophen, Aspirin (Nsaid) and Caffeine, tablets USP, 250 mg/250 mg/65, distributed in New Jersey, New York, Pennsylvania. The recall was initiated on 11 Jul 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0641-2024
- FDA event ID
- 94966
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurohealth LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Jul 2024
- FDA classified
- 20 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 11 Jul 2024 | Recall initiated by company | |
| 20 Aug 2024 | Classified by FDA | +40 days |
| 28 Aug 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Product as listed by the FDA
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.
Where it was distributed
NJ, NY & PA
Questions about this recall
Why was it recalled?
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Which lots are affected?
Lot#: AC2523005A, Exp 6/30/2025
Where was it sold?
NJ, NY & PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Acetaminophen recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |