TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Zydus Pharmaceuticals USA Inc

NDC code

68382-141-14

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0015-2015

Other Topiramate recalls

See all

Class III · Low risk Ongoing Jul 6, 2026

Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions…

Reason Failed Dissolution Specifications

Supernus Pharmaceuticals, Inc. NDC 17772-101-30 D-0758-2026

Class III · Low risk Terminated Dec 8, 2023

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA…

Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…

Azurity Pharmaceuticals, Inc. NDC 52652-9001-1 D-0213-2024

Class III · Low risk Terminated Oct 25, 2021

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road…

Reason Discoloration

Unichem Pharmaceuticals USA INC NDC 29300-116-05 D-0255-2022

Class II · Moderate risk Terminated Mar 15, 2021

Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 17772-103-30 D-0570-2021

Class II · Moderate risk Terminated Jul 27, 2020

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun…

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 47335-0707-13 D-1520-2020