Precision Dose Carbamazepine Oral Suspension Recall: Labeling Error
Precision Dose recalls Carbamazepine Oral Suspension due to labeling error in product carton. The carton lists incorrect volume and NDC number, but unit dose cups are correctly labeled.
Lower-risk recall
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Contact the company
What happened, in plain English
Precision Dose is recalling Carbamazepine Oral Suspension (100 mg/5 mL) because the product carton has incorrect volume and NDC numbers, while the unit dose cups are labeled correctly. This labeling error could lead to confusion about the product's strength or quantity. Read more at govinfonow.com/recall/41515-precision-dose-carbamazepine-oral-suspension-recall-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/41515-precision-dose-carbamazepine-oral-suspension-recall-labeling-error · Updated October 8, 2026 · FDA enforcement record: FDA #D-1037-2017
Cite this page
“Precision Dose Carbamazepine Oral Suspension Recall: Labeling Error.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41515-precision-dose-carbamazepine-oral-suspension-recall-labeling-error. Based on FDA recall #D-1037-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2017%22&limit=1).
Why it’s dangerous
The product carton lists incorrect volume and NDC numbers, but the unit dose cups are correctly labeled. This labeling error could cause confusion about the product's strength or quantity, potentially leading to incorrect dosing.
Who’s affected
Prescription patients using Carbamazepine Oral Suspension from Precision Dose. Those with the specific NDC number 68094-301-59 and lot number 500326 are most at risk.
How to tell if you have this one
Check for the NDC number 68094-301-59 and lot number 500326 on the product carton. The unit dose cups are correctly labeled but the carton has incorrect information.
- Brand
Precision Dose- Category
Drug
What to do — step by step
Check Product Carton
Look for the NDC number 68094-301-59 and lot number 500326 on the product carton.
Where it went and when
Where it was distributed
Distributed in Connecticut and Ohio.
FDA distribution: “OH and CT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Ohio.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1037-2017 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1037-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.