Pain relief caplets recalled because the box names the wrong drug
Aero Healthcare is recalling two lots of AERO TAB caplets because the outer box states acetaminophen and caffeine while the inner pouch correctly states aspirin and caffeine.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the outer label names a different active ingredient than the product actually contains, and no injuries are reported.
Plain-English summary
AERO TAB caplets, packaged two caplets per packet in a 50-count box, manufactured for Aero Healthcare US of Valley Cottage, New York, NDC 55305-135-01, are being recalled for a label mix-up.
The issue affects the outer box labeling only. The box incorrectly states the ingredients as Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID) 500mg and Caffeine 32.5mg.
The recall covers lot 9282 (expiring 1 September 2026) and lot 9310 (expiring 1 November 2026). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Anyone who avoids aspirin, including people advised against NSAIDs, would not learn from the box that the caplets contain it. Anyone holding an affected lot should stop using it and follow the firm's instructions.
The recalled product
- Product
- AEROTAB PAIN RELIEVER (PAIN RELIEVER)
- Brand
- AEROTAB PAIN RELIEVER
- Manufacturer
- Aero Healthcare
- Category
- Drug — Analgesic
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 (4)
- Lot # 9282
- Exp Date: 2026-09-01
- Lot # 9310
- Exp Date: 2026-11-01
Distribution
Distributed nationwide across the United States.
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