Famotidine Tablets recall: Labeling Error
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Why was Famotidine Tablets recalled?
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
FA2022001B, Exp 03/2025
- Product
- Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
- Recalling firm
- Glenmark Therapeutics, Inc.
- Quantity
- 19,968 bottles
- Distribution
- Nationwide in the USA
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)