CLASS II Drug recall · Reported 26 Jul 2023 · FDA Enforcement Report
Famotidine Tablets, USP, 20mg bottle within recalled
Glenmark Therapeutics is recalling Famotidine Tablets, USP, 20mg bottle within a, distributed nationwide in the US. The recall was initiated on 1 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0939-2023
- FDA event ID
- 92565
- Recalling firm
- Glenmark Therapeutics, Mahwah, NJ
- Brand
- Famotidine
- Manufacturer
- GLENMARK THERAPEUTICS INC., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2023
- FDA classified
- 21 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 1 May 2023 | Recall initiated by company | |
| 21 Jul 2023 | Classified by FDA | +81 days |
| 26 Jul 2023 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
FA2022001B, Exp 03/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Famotidine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine | Aurobindo Pharma USA | Other | 4 states |
| Drug | CLASS III | Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine | HF Acquisition | Temperature Abuse | CT |
| Drug | CLASS III | Famotidine tablets, 10 mg recalled by Dr. Reddy's LaboratoriesFamotidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |