Precision Dose Acetaminophen Suspension Recall: Contaminated Raw Ingredient Risk
Precision Dose recalls acetaminophen oral suspension due to contaminated raw ingredients. Affected lots include 503679, 503693, 503715. Stop using and contact for details.
Recall notice
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Contact the company
What happened, in plain English
Precision Dose is recalling acetaminophen oral suspension products that were made with contaminated raw ingredients. This could pose a health risk if the product is used as intended. Read more at govinfonow.com/recall/35577-precision-dose-acetaminophen-suspension-recall-contaminated-raw-ingredient-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35577-precision-dose-acetaminophen-suspension-recall-contaminated-raw-ingredient-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0095-2022
Cite this page
“Precision Dose Acetaminophen Suspension Recall: Contaminated Raw Ingredient Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35577-precision-dose-acetaminophen-suspension-recall-contaminated-raw-ingredient-risk. Based on FDA recall #D-0095-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0095-2022%22&limit=1).
Why it’s dangerous
The product was manufactured with contaminated raw ingredients, which could lead to health issues if consumed. The contamination occurred during the production process, potentially introducing harmful substances into the product.
Who’s affected
People who own or use the recalled acetaminophen oral suspension products. Hospital staff using the product are most at risk due to the hospital-only labeling.
How to tell if you have this one
Check for the product name 'Acetaminophen Oral Suspension, 325 mg/10.15 mL' with NDC numbers 68094-330-59 (individual cup), 68094-330-62 (30-count case), or 68094-330-61 (100-count case). The affected lots are 503679, 503693, and 503715.
- Brand
Precision Dose- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide USA- NDC
68094-231-59, 68094-231-62, 68094-231-61, 68094-231-01, 68094-231-58, 68094-330-59, 68094-330-62, 68094-330-61, 68094-030-59, 68094-030-62
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0094-2022 | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.; Lot#: 503670 | 166,920 unit dose cups |
| D-0095-2022 | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.; Lot#: 503679, 503693, 503715 | 151,100 unit dose cups |
What to do — step by step
Check Product Details
Look for the NDC numbers 68094-330-59, 68094-330-62, or 68094-330-61 on the packaging.
Contact Manufacturer
Reach out to Precision Dose Inc. for further instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0095-2022 (November 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0095-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.