Pain reliever medication recalled for outer box labeling mismatch
Aero Healthcare recalls AEROTAB PAIN RELIEVER due to incorrect ingredient listing on the outer box packaging. The inner pouch contains correct labeling.
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: This recall involves a medication with incorrect labeling that lists different active ingredients on the outer box versus the actual product contents. While no injuries or illnesses have been reported, the mislabeling of a pharmaceutical product with different drug classes (aspirin versus acetaminophen) creates a potential risk of harm if consumers take the product without checking the inner pouch labeling.
Plain-English summary
Aero Healthcare is recalling AEROTAB PAIN RELIEVER caplets nationwide due to incorrect labeling on the product box. The outer box states the ingredients as Acetaminophen 500mg and Caffeine 65mg, while the inner pouch correctly lists the actual ingredients as Aspirin 500mg and Caffeine 32.5mg.
The affected product is packaged as 2 caplets per packet in 50-count boxes. Two lot numbers are involved: Lot #9282 (expiration September 1, 2026) and Lot #9310 (expiration November 1, 2026).
The FDA has classified this as a Class II recall. Consumers who have purchased affected lots should check their product packaging to confirm the correct ingredient information.
The recalled product
- Product
- AEROTAB PAIN RELIEVER (PAIN RELIEVER)
- Brand
- AEROTAB PAIN RELIEVER
- Manufacturer
- Aero Healthcare
- Hazard
- labeling-error
- ingredient-mismatch
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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