Acetaminophen Recall: Aero Healthcare 50-count box caplets
Announced 2025-11-12 · FDA
The recall concerns Aero Healthcare Acetaminophen 500 mg/Caffeine 65 mg caplets in a 50-count box due to a label mix-up on the outer box. The outer box lists acetaminophen 500 mg and caffeine 65 mg, while the inner pouch correctly states aspirin 500 mg and caffeine 32.5 mg. Lot # 9282 (exp 2026-09-01) and Lot # 9310 (exp 2026-11-01) are affected, distributed nationwide in the US.
| Brand | Aero Healthcare |
|---|---|
| Product | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 |
| Reason | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. |
| Severity | moderate |
| Units affected | N/A |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01 |
WHAT YOU SHOULD DO
- Stop using any caplets from the recalled lots immediately.
- Check the packaging for Lot # 9282 or Lot # 9310 and the expiration dates to determine if your product is recalled.
- Contact Aero Healthcare US for instructions on replacement, refund, or disposal per recall guidance.
- If you experience any adverse effects, seek medical advice promptly.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.