US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 21, 2013 (13 years ago)

Children's Acetaminophen Oral Suspension

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

What was recalled

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.

Recalling firm
Precision Dose Inc.
NDC code
68094-650-59
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-250-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Acetaminophen recalls

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Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0522-01 D-0255-2026
Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0523-01 D-0254-2026
Class II · Moderate risk Ongoing

Tylenol

Reason Defective Container

Kenvue Brands LLC D-0121-2026
Class II · Moderate risk Ongoing

Acetaminophen 500mg Caffeine 65mg caplets

Reason 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.

Aero Healthcare NDC 55305-135-01 D-0155-2026