Glenmark Recalls Topiramate Tablets Due to Off-Odor Complaints
Glenmark Generics Inc. is recalling Topiramate Tablets due to complaints of a moldy, musty, or fishy odor. The recall covers 9,624 bottles distributed nationwide.
What this means for you
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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a sensory defect (odor) rather than a confirmed toxicological hazard or injury.
Plain-English summary
Glenmark Generics Inc. is recalling Topiramate Tablets, 200 mg, 60-count bottles (NDC 68462-110-60). The recall was initiated due to complaints regarding an off-odor described as moldy, musty, or fishy in nature.
The affected product is Lot # 02123782 with an expiration date of 11/14. A total of 9,624 bottles were distributed nationwide. The medication is a prescription-only drug manufactured by Glenmark Generics Ltd. in India for Glenmark Generics USA in Mahwah, NJ.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- TOPIRAMATE (TOPIRAMATE)
- Brand
- TOPIRAMATE
- Manufacturer
- Glenmark Generics Inc., USA
- Category
- Drug — Prescription Medication
- Affected units
- 9,624
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# 02123782
- Exp 11/14
UPCs (3)
- 0368462109601
- 0368462153604
- 0368462110607
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Glenmark Generics Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · TOPIRAMATE
- LowTopiramate 50 mg tablets recalled due to discoloration
FDA (Drugs) · 2021-12-01
- ModerateZydus Recalls Topiramate 200 mg Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2014-10-22
Same manufacturer · Glenmark Generics Inc., USA
See all →- SevereGlenmark Recalls Ranitidine Tablets Due to Foreign Metoprolol Contamination
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- LowGlenmark Recalls Gabapentin Tablets Due to Chemical Contamination and Off-Odor
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- ModerateGlenmark Recalls Pravastatin Sodium Tablets Due to Off-Odor Complaints
FDA (Drugs) · 2013-05-22
- LowGlenmark Recalls Montelukast Sodium Tablets Due to Chemical Contamination
FDA (Drugs) · 2013-03-13
- ModerateGlenmark Recalls Naproxen Sodium Tablets Due to Labeling Error
FDA (Drugs) · 2012-10-03
Same hazard · odor complaint
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FDA (Drugs) · 2018-05-02
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FDA (Drugs) · 2018-01-31
- ModerateDr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints
FDA (Drugs) · 2013-03-06