FDA Recall D-0155-2026

Aero Healthcare · Valley Cottage, NY

Class II Ongoing 209 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01

Quantity: N/A

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 record

Recall number: D-0155-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide.
Recall initiated: 2025-10-17
Classified by FDA Center: 2025-11-05
FDA published: 2025-11-12
Recalling firm: Aero Healthcare
Firm location: Valley Cottage, NY

Drug identification

Brand name(s): AEROTAB PAIN RELIEVER
Generic name(s): PAIN RELIEVER
Manufacturer(s): Aero Healthcare
NDC(s): 55305-135
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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