Prescription Oral Solution Eprontia Recalled for Out-of-Specification Impurity
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is an out-of-specification chemical impurity detected during routine stability testing, representing a manufacturing quality issue rather than a reported safety event.
Plain-English summary
Azurity Pharmaceuticals, Inc. is recalling Eprontia (topiramate) oral solution, 25 mg/mL in 473 mL bottles. The affected product is Lot #MB22020B with expiration date 12/27/2023. Approximately 2,220 bottles were distributed nationwide.
The recall was issued following the detection of an out-of-specification impurity, 4,5-desisopropylidene topiramate, during routine stability testing at 18 months. This chemical degradation product exceeded acceptable specifications, raising concerns about the pharmaceutical's purity and integrity.
Patients currently taking Eprontia from Lot #MB22020B should consult their healthcare provider or pharmacist. Healthcare providers should verify whether their inventory includes this lot and ensure it is not dispensed to patients. For additional information, patients and healthcare providers should contact Azurity Pharmaceuticals or the FDA.
The recalled product
- Product
- EPRONTIA (TOPIRAMATE)
- Brand
- EPRONTIA
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 2,220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: MB22020B
- Exp 12/27/2023
Distribution
Distributed nationwide across the United States.
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