Topiramate recalls: 6 FDA reports
Recalls involving Topiramate. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
0Ongoing
2024-01-10Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceutica
D-0213-2024 · Class III · reported 2024-01-10 · Terminated
- 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.
- Product
- Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
- Where it went
- USA nationwide.
- How much
- 2,220 bottles
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Are
D-0255-2022 · Class III · reported 2021-12-01 · Terminated
- Why it was recalled
- Discoloration
- Product
- Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
- Where it went
- Nationwide within the United States
- How much
- 1284 bottles
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharm
D-0570-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
- Where it went
- FL, GA, SC
- How much
- 490 bottles
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Cata
D-0112-2017 · Class II · reported 2016-10-26 · Terminated
- Why it was recalled
- Superpotent Drug: Failure of assay specifications in the capsule.
- Product
- Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
- Where it went
- Nationwide
- How much
- 17,128 (30-count blister packs)
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India
D-0015-2015 · Class II · reported 2014-10-22 · Terminated
- Why it was recalled
- Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
- Product
- TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
- Where it went
- U.S. Nationwide
- How much
- 14,568 Bottles
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark G
D-331-2013 · Class III · reported 2013-05-22 · Terminated
- Why it was recalled
- Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
- Product
- Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
- Where it went
- Nationwide
- How much
- 9624 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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