CLASS II Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Acetaminophen Oral Suspension, 160 mg recalled by Precision Dose
Precision Dose is recalling Acetaminophen Oral Suspension, 160 mg, distributed nationwide in the US. The recall was initiated on 1 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0094-2022
- FDA event ID
- 88976
- Recalling firm
- Precision Dose, South Beloit, IL
- Brand
- Acetaminophen
- Manufacturer
- Precision Dose, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2021
- FDA classified
- 5 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 1 Nov 2021 | Recall initiated by company | |
| 5 Nov 2021 | Classified by FDA | +4 days |
| 17 Nov 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Product as listed by the FDA
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.
Where it was distributed
Nationwide USA
Questions about this recall
Is Acetaminophen Oral Suspension, 160 mg recalled?
Yes. Precision Dose recalled Acetaminophen Oral Suspension, 160 mg on 1 Nov 2021. The recall is Class II and its status is Terminated. Recall number D-0094-2022.
Why was it recalled?
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Which lots are affected?
Lot#: 503670
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Precision Dose
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 325 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorhexidine Gluconate Oral Rinse recalled by Precision Dose | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Carbamazepine Oral Suspension USP, 100 mg/ Unit Dose Cups recalled | Precision Dose | Potency & Assay | Nationwide |
Other Acetaminophen recalls
All 46| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |