Eprontia — Class III drug recall D-0213-2024
Terminated recall by Azurity Pharmaceuticals, Inc., reported 2024-01-10, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramat
| Recall number | D-0213-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Azurity Pharmaceuticals, Inc., Wilmington, MA, United States |
| Recall initiated | 2023-12-08 |
| Classified | 2024-01-02 |
| Reported by FDA | 2024-01-10 |
| Terminated | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 2,220 bottles |
| Reason classes | specification failure |
| NDC | 52652-9001, 52652-9001-01, 52652-9001-02, 52652-9001-03 |
| Lot numbers | MB22020B |
| Expiration dates | 2023-12-27 |
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 for recall
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0213-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.