Class III · Low risk
Trokendi XR
Failed dissolution specifications.
Eprontia (topiramate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Affected NDC
52652-9001-01
Compare with the code on your package — it is the most precise check available.
Drug: Topiramate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Eprontia Topiramate NDC 52652-9001 |
25 mg/mL | Solution Oral |
Azurity Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- NDC code
- 52652-9001-1
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0213-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Topiramate recalls
See all
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Trokendi XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Topiramate 25mg Tabs White/round tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Other recalls by Azurity Pharmaceuticals, Inc.
All 2023 recalls
Class I · High risk
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
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