[pending] AEROTAB PAIN RELIEVER (PAIN RELIEVER)
Pending LLM rewrite. Source: FDA_DRUG D-0155-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- AEROTAB PAIN RELIEVER (PAIN RELIEVER)
- Brand
- AEROTAB PAIN RELIEVER
- Manufacturer
- Aero Healthcare
- Category
- Drug — Drugs
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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