FDA Announces Class II Recall of AERO TAB Pain Reliever Due to Labeling Mix-Up
Key Clinical Summary
- Class II recall of AERO TAB acetaminophen 500mg/caffeine 65mg due to outer box label mix-up; inner pouches contain aspirin 500mg/caffeine 32.5mg.
- Lots 9282 and 9310 affected; distributed nationwide; recall ongoing as of November 2025.
- Risk for non-steroidal anti-Inflammatory drug (NSAID)-related adverse events in patients contraindicated for aspirin; pharmacists should quarantine stock and alert consumers.
The US Food and Drug Administration (FDA) announced a Class II recall of AERO TAB acetaminophen 500mg and caffeine 65mg caplets, manufactured for Aero Healthcare US in Valley Cottage, NY. The affected product is distributed nationwide in 50-count boxes containing individually packaged 2-caplet pouches (NDC 55305-135-01). The recall impacts lot #9282 (Exp. 09/2026) and lot #9310 (Exp. 11/2026).
The recall was initiated voluntarily by the firm following the discovery of a labeling mix-up on the outer carton. While the box lists the product as containing acetaminophen 500mg and caffeine 65mg, the inner pouches are correctly labeled and actually contain aspirin (NSAID) 500mg and caffeine 32.5mg. The incorrect outer label could lead to confusion for consumers or health care professionals, potentially affecting patient safety if taken by individuals who should avoid NSAIDs, such as those with peptic ulcer disease or on anticoagulant therapy.
The FDA classified the recall as Class II on November 5, 2025, indicating that exposure to the mislabeled product may cause temporary or medically reversible adverse health consequences. The recall remains ongoing, and no press release has been issued by the company.
Pharmacists are advised to check stock for the listed lot numbers and remove affected products from shelves. The product, marketed for temporary relief of headache or pain associated with tension or fatigue, is commonly used as an over-the-counter analgesic and stimulant combination.
