South Beloit, IL, United States
Precision Dose Inc. recalls
4 recalls recorded since 2018, most recently on 14 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 14 July 2026
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0741-2026
- Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Terminated Class II Drugs
- Recall started
- 1 November 2021
- Terminated
- 14 July 2024
- Reason
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0095-2022, D-0094-2022
- 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: 68094-3
- 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), Ho
Terminated Class II Drugs
- Recall started
- 1 January 2021
- Terminated
- 14 July 2024
- Reason
- cGMP deviations: The firm was notified of the manufacturer's expanded recall.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0228-2021
- Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South
Terminated Class II Drugs
- Recall started
- 13 November 2019
- Terminated
- 17 September 2022
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1004-2020
- Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.