# FDA recall D-0155-2026

> **Aero Healthcare** · Class II · drug recall initiated 2025-10-17.

## 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 for recall

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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0155-2026
- **Recalling firm:** Aero Healthcare
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-17
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valley Cottage, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2026

## Citation

> AI Analytics. FDA recall D-0155-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0155-2026. Source: US FDA. Licensed CC0.

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