Use caution Drug recall · FDA · Published March 21, 2013

Precision Dose Recalls Children's Acetaminophen Due to Misleading Labeling

Precision Dose Inc. recalls Children's Acetaminophen Oral Suspension because the 650 mg dose is an adult strength, making the 'Children's' label misleading.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-250-2013Drug Precision Dose ›

Use caution until it’s fixed

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.

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Contact the company

Recalling firmPrecision Dose Inc.722 Progressive Ln · South Beloit, IL 61080-2616

✎ GovInfoNow plain-language explainer

Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension unit dose cups because the product name is misleading. Although labeled for children, each cup contains a 650 mg dose of acetaminophen, which is an adult dosage strength. The record does not specify a remedy or instructions for consumers. Read more at govinfonow.com/recall/48217-precision-dose-inc-recalls-children-s-acetaminophen-oral-suspension-650.

Source Summary by GovInfoNow · govinfonow.com/recall/48217-precision-dose-inc-recalls-children-s-acetaminophen-oral-suspension-650 · Updated October 13, 2026 · FDA enforcement record: FDA #D-250-2013

Cite this page

“Precision Dose Recalls Children's Acetaminophen Due to Misleading Labeling.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48217-precision-dose-inc-recalls-children-s-acetaminophen-oral-suspension-650. Based on FDA recall #D-250-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-250-2013%22&limit=1).

The FDA announced on March 21, 2013, that Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension because the label misleadingly identifies a 650 mg adult dose as for children. The agency issued recall number D-250-2013.

How to tell if you have it

Brand: Precision Dose
Product: Children's Acetaminophen Unit Dose Cups
NDC: 68094-650-59 (30-count cups)
Lot codes: 101456, 101488, 101499, 101503, 101537, 101552, 101554, 101611, 101616, 101623, 101630, 101754
Expiration dates: 05/13 through 03/14
Distribution: Nationwide and Puerto Rico

The hazard

The product's name includes the word "Children's," which is misleading because the 650 mg dose of acetaminophen contained within it is an adult dose.

Context

GovInfoNow's records show Precision Dose Inc. has had six other recalls since July 5, 2017. Other recent recalls include a Glycopyrrolate Oral Solution recall dated July 14, 2026, and an Acetaminophen Suspension recall dated Nov. 1, 2021. A Chlorhexidine Rinse recall occurred on Jan. 1, 2021, involving cGMP deviations.

How to tell if you have this one

Check your unit dose cups for the product name "Children's Acetaminophen Oral Suspension" and NDC 68094-650-59. Look for lot numbers including 101456, 101488, 101499, 101503, 101537, 101552, 101554, 101611, 101616, 101623, 101630, or 101754 with expiration dates ranging from May 2013 to March 2014.

Brand
Precision Dose
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Product
Verify if you have the recalled unit dose cups by checking the NDC number and lot numbers listed in the recall details.
Consult a Professional
Since the remedy is not stated in the record, contact your healthcare provider or pharmacist for advice on how to handle this specific product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Mar 21, 2013Firm started the recall
Apr 15, 2013FDA classified it Class II
Apr 24, 2013Published in FDA’s Enforcement Report
May 7, 2015FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed nationwide and in Puerto Rico.

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Link to this recall

<a href="https://govinfonow.com/recall/48217-precision-dose-inc-recalls-children-s-acetaminophen-oral-suspension-650">Precision Dose Recalls Children's Acetaminophen Due to Misleading Labeling (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-250-2013 (March 21, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-250-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.