CLASS III ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Ezetimibe and Simvastatin Tablets, 10mg/40mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets, 10mg/40mg, distributed nationwide in the US. The recall was initiated on 19 May 2025 and the FDA has classified it as Class III.
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-0462-2025
- FDA event ID
- 96884
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 May 2025
- FDA classified
- 10 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 19 May 2025 | Recall initiated by company | |
| 10 Jun 2025 | Classified by FDA | +22 days |
| 18 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Where it was distributed
Nationwide USA and PR
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Which lots are affected?
Lot #: 17240195, Exp 01/31/2026.
Where was it sold?
Nationwide USA and PR
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 9 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Ezetimibe recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ezetimibe and Simvastatin Tablets, 10 mg/80mg recalledEzetimibe And Simvastatin | Golden State Medical Supply | Potency & Assay | AZ, MO |
| Drug | CLASS II | Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalledEzetimibe And Simvastatin | Golden State Medical Supply | Potency & Assay | AZ, MO |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |