CLASS III Drug recall · Reported 10 Jan 2024 · FDA Enforcement Report
Eprontia (topiramate) oral solution, 25 mg/mL recalled
Azurity Pharmaceuticals is recalling Eprontia (topiramate) oral solution, 25 mg/mL, distributed nationwide in the US. The recall was initiated on 8 Dec 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0213-2024
- FDA event ID
- 93552
- Recalling firm
- Azurity Pharmaceuticals, Wilmington, MA
- Brand
- Eprontia
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Dec 2023
- FDA classified
- 2 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 8 Dec 2023 | Recall initiated by company | |
| 2 Jan 2024 | Classified by FDA | +25 days |
| 10 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Where it was distributed
USA nationwide.
Questions about this recall
Is Eprontia (topiramate) oral solution, 25 mg/mL recalled?
Yes. Azurity Pharmaceuticals recalled Eprontia (topiramate) oral solution, 25 mg/mL on 8 Dec 2023. The recall is Class III and its status is Terminated. Recall number D-0213-2024.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Which lots are affected?
Lot #: MB22020B, Exp 12/27/2023
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Azurity Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Firvanq (vancomycin hydrochloride for oral solution) recalledFirvanq | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
Other Topiramate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Trokendi XR, topiramate extended-release capsules, 25mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals UsaTopiramate | Unichem Pharmaceuticals Usa | Other | Nationwide |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsules 100 mg recalledTrokendi Xr | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsule, 50mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |