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

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…

Recall #: D-0155-2026
Affected scope: N/A
Initiated: October 17, 2025

Compiled from official public sources by the publisher. · Updated September 2026

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Aero Healthcare recalled Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packa… - a moderate-severity action.

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packa… was recalled by Aero Healthcare in November 12, 2025. Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingred…. Check the official notice for the remedy. Verify recall #D-0155-2026 with the FDA Drug before acting.

The recall

Aero Healthcare issued this moderate-severity FDA Drug recall-Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingred….

Moderate
severity level: Class II
classification: November 12, 2025
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0155-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	D-0155-2026
Date reported	November 12, 2025
Date initiated	October 17, 2025
Recalling firm	Aero Healthcare
Firm location	Valley Cottage, NY
Affected scope	N/A
Distribution	US Nationwide.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0155-2026) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 12, 2025. Severity: Moderate. Recall number: D-0155-2026.

Where was the recalled product distributed? ▼

Distribution: US Nationwide..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Drug, reported November 12, 2025. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026