Precision Dose Carbamazepine Oral Suspension Recall: Subpotent Drug Risk
Precision Dose recalls 10-count carbamazepine oral suspension cups due to low drug potency. This may result in ineffective treatment. Check your product details and contact the manufacturer for guidance.
Lower-risk recall
Subpotent Drug: low out of specification results.
Contact the company
What happened, in plain English
Precision Dose is recalling carbamazepine oral suspension cups that may have low drug potency. This could lead to ineffective treatment if used as prescribed. The recall is for specific product packaging with a lot number. Read more at govinfonow.com/recall/41170-precision-dose-carbamazepine-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41170-precision-dose-carbamazepine-oral-suspension-recall-subpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0057-2018
Cite this page
“Precision Dose Carbamazepine Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41170-precision-dose-carbamazepine-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-0057-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0057-2018%22&limit=1).
Why it’s dangerous
The medication may have lower-than-stated potency due to manufacturing issues. This could mean the dose is less effective than intended, potentially leading to inadequate seizure control.
Who’s affected
People prescribed carbamazepine who own the specific 10-count cup packaging with lot number 500105. Those using the product for seizure management are most at risk.
How to tell if you have this one
Check for the product name 'Carbamazepine Oral Suspension USP, 100 mg/5 mL' in 10-count cups per tray. The lot number 500105 and expiration date 04/30/18 are key identifiers.
- Brand
Precision Dose- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 500105 and expiration date 04/30/18 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates potential lower potency, but the product is still safe to use if it meets the specifications. Contact Precision Dose for specific guidance.
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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-0057-2018 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0057-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.