Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Eprontia (topiramate) oral solution Recalled by Azurity Pharmaceuticals, Inc. Due to Failed Impurities/Degradation Specifications: Out of specification Impurity C...

Date: December 8, 2023
Company: Azurity Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Azurity Pharmaceuticals, Inc. directly.

Affected Products

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

Quantity: 2,220 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Azurity Pharmaceuticals, Inc.

Azurity Pharmaceuticals, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report