FDA Drug recall D-0213-2024
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 526…
- FDA Drug
- Class III
- terminated
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class III recall of Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 526… by Azurity Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0213-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-12-08 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Azurity Pharmaceuticals |
| Distribution | US |
Product
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Reason
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Identifiers
| ndc | 52652-9001-1 |
|---|---|
| ndc | 52652-9001-2 |
| ndc | 52652-9001-3 |
| code_info | Lot #: MB22020B, Exp 12/27/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.