Precision Dose Inc.
FDA Regulatory Profile
Precision Dose Inc. has 8 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0741-2026 · Class II · Jul 14, 2026
- Latest inspection
- Sep 11, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 8 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0741-2026 | Class II | Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S… | Jul 14, 2026 |
| D-0094-2022 | Class II | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup… | Nov 1, 2021 |
| D-0095-2022 | Class II | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup… | Nov 1, 2021 |
| D-0228-2021 | Class II | Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack… | Jan 1, 2021 |
| D-1004-2020 | Class II | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62… | Nov 13, 2019 |
| D-0057-2018 | Class III | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in… | Sep 25, 2017 |
| D-1037-2017 | Class II | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose… | Jul 5, 2017 |
| D-250-2013 | Class II | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged… | Mar 21, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Sep 11, 2025 | South Beloit, IL | Drugs | Voluntary Action Indicated (VAI) | 1419861 |
| Jan 28, 2019 | South Beloit, IL | Drugs | Voluntary Action Indicated (VAI) | 1419861 |
| May 12, 2017 | South Beloit, IL | Drugs | No Action Indicated (NAI) | 1419861 |
| Jan 27, 2017 | South Beloit, IL | Drugs | No Action Indicated (NAI) | 1419861 |
| Oct 3, 2011 | South Beloit, IL | Drugs | No Action Indicated (NAI) | 1419861 |
| May 2, 2011 | South Beloit, IL | Drugs | No Action Indicated (NAI) | 1419861 |
| Nov 24, 2009 | South Beloit, IL | Drugs | Voluntary Action Indicated (VAI) | 1419861 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1419861 | South Beloit, IL | 7 | Sep 11, 2025 |