Precision Dose recalls
Precision Dose appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2013-04-24 to 2026-07-29 |
| By agency | FDA Drug (8) |
| By classification | Class II (7), Class III (1) |
| By status | terminated (7), ongoing (1) |
| Distribution named in notices | CT, OH, US |
Recalls
- Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, ND…
FDA Drug · Class II · 2026-07-29 · Precision Dose
Reason: Failed Impurities/Degradation Specifications - 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 3…
FDA Drug · Class II · 2021-11-17 · Precision Dose
Reason: cGMP Deviations: Product manufactured with contaminated raw ingredient. - 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…
FDA Drug · Class II · 2021-11-17 · Precision Dose
Reason: cGMP Deviations: Product manufactured with contaminated raw ingredient. - 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…
FDA Drug · Class II · 2021-01-20 · Precision Dose
Reason: cGMP deviations: The firm was notified of the manufacturer's expanded recall. - Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62
FDA Drug · Class II · 2020-03-18 · Precision Dose
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. - Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per cas…
FDA Drug · Class III · 2017-11-08 · Precision Dose
Reason: Subpotent Drug: low out of specification results. - Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-30…
FDA Drug · Class II · 2017-08-09 · Precision Dose
Reason: Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC. - Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC…
FDA Drug · Class II · 2013-04-24 · Precision Dose
Reason: 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…