Acetaminophen Oral Suspension Recalled Due to Contaminated Raw Ingredient
Precision Dose Inc. is recalling Acetaminophen Oral Suspension (325 mg/10.15 mL) due to contaminated raw ingredient used in manufacturing. The recall affects 151,100 unit dose cups distributed nationwide for hospital use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this recall as Class II. The source states only that contaminated raw ingredient was used in manufacturing; no illnesses, injuries, or specific contaminant identity are reported. This meets the criteria for Moderate severity as a Class II recall without documented harm.
Plain-English summary
Precision Dose Inc. is recalling Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup, due to the use of contaminated raw ingredient in manufacturing. The product was manufactured in violation of current Good Manufacturing Practice (cGMP) requirements.
The recalled product includes 151,100 unit dose cups distributed nationwide for hospital use only. Affected lot numbers are 503679, 503693, and 503715. The product was distributed in 30-count and 100-count cases under NDC numbers 68094-330-59 (individual cup), 68094-330-62 (30-count case), and 68094-330-61 (100-count case).
Healthcare facilities that have received this product should stop distribution and quarantine remaining stock. Patients and healthcare providers should contact Precision Dose Inc. or consult with a healthcare provider regarding appropriate next steps for affected doses.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- Precision Dose Inc.
- Hazard
- contaminated-raw-ingredient
- cGMP-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: 503679
- 503693
- 503715
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ACETAMINOPHEN
- ModerateFDA recalls Baxter acetaminophen injection for discoloration defect
FDA (Drugs) · 2025-09-03
- SevereFDA Recalls Acetaminophen Injection Due to Labeling Mix-up
FDA (Drugs) · 2024-08-28
- SevereAcetaminophen tablets incorrectly labeled with aspirin drug facts information
FDA (Drugs) · 2024-08-14
- ModerateExtra Strength Acetaminophen 500mg Tablets Recalled for Discoloration
FDA (Drugs) · 2024-07-03
- HighAcetaminophen Injection Recalled for Temperature Storage Abuse Nationwide
FDA (Drugs) · 2022-08-24
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27