Precision Dose recalls
FDA enforcement reports naming Precision Dose Inc. as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Jul 29, 2026
- Jul 29, 2026Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, I…Drug · Precision Dose Inc.Failed Impurities/Degradation SpecificationsClass II
- Nov 17, 2021Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cu…Drug · Precision Dose Inc.cGMP Deviations: Product manufactured with contaminated raw ingredient.Class II
- Nov 17, 2021Acetaminophen Oral Suspension, 325 mg/10Drug · Precision Dose Inc.cGMP Deviations: Product manufactured with contaminated raw ingredient.Class II
- Jan 20, 2021Chlorhexidine Gluconate Oral Rinse USP 0Drug · Precision Dose Inc.cGMP deviations: The firm was notified of the manufacturer's expanded recall.Class II
- Mar 18, 2020Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per caseDrug · Precision Dose Inc.CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.Class II
- Nov 8, 2017Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59),…Drug · Precision Dose Inc.Subpotent Drug: low out of specification results.Class III
- Aug 9, 2017Carbamazepine Oral Suspension, USPDrug · Precision Dose Inc.Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.Class II
- Apr 24, 2013Children's Acetaminophen Oral Suspension, 650 mg/20Drug · Precision Dose Inc.Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is a…Class II