Azurity Eprontia oral solution recall: Impurity risk in topiramate solution
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution due to impurity detected in stability testing. This medication is prescription-only and may pose risks if impurities are present.
Recall notice
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Contact the company
What happened, in plain English
Azurity Pharmaceuticals is recalling a specific prescription topiramate oral solution product due to impurities found during stability testing. This could potentially affect medication safety if the impurities are present in the solution. Read more at govinfonow.com/recall/32932-azurity-eprontia-oral-solution-recall-impurity-risk-in-topiramate-solution.
Source Summary by GovInfoNow · govinfonow.com/recall/32932-azurity-eprontia-oral-solution-recall-impurity-risk-in-topiramate-solution · Updated August 17, 2026 · FDA enforcement record: FDA #D-0213-2024
Cite this page
“Azurity Eprontia oral solution recall: Impurity risk in topiramate solution.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32932-azurity-eprontia-oral-solution-recall-impurity-risk-in-topiramate-solution. Based on FDA recall #D-0213-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2024%22&limit=1).
Why it’s dangerous
The recall is based on impurities detected during routine stability testing at 18 months. This impurity (4,5-desisopropylidene topiramate) could potentially affect the medication's safety and effectiveness if present in the solution.
Who’s affected
Prescription patients using Eprontia (topiramate) oral solution from Azurity Pharmaceuticals. Those with the specific NDC 52652-9001-1 lot number MB22020B are most at risk.
How to tell if you have this one
Check for the product name Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL bottle, prescription-only. The specific lot number MB22020B (expiring 12/27/2023) is part of the recalled batch.
- Brand
Azurity- Category
Drug
What to do — step by step
Check Product Details
Identify the product by checking the NDC code 52652-9001-1 and lot number MB22020B on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 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.
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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-0213-2024 (December 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0213-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.