Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
Famotidine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
72657-0113-20
Compare with the code on your package — it is the most precise check available.
Drug: Famotidine Category: Heartburn & Stomach Medication
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 |
|---|---|---|---|---|
| Famotidine NDC 72657-0113 |
20 mg/1 | Tablet, Film Coated Oral |
Glenmark Therapeutics INC., USA | OTC |
- Recalling firm
- Glenmark Therapeutics, Inc.
- NDC code
- 72657-113-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0939-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Famotidine recalls
See all
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Other labeling / mix-up recalls from 2023
All labeling / mix-up recalls
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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