CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Pravastatin Sodium Tablets USP, 20 mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 25 Mar 2019 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-1120-2019
- FDA event ID
- 82461
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Pravastatin Sodium
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2019
- FDA classified
- 11 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 25 Mar 2019 | Recall initiated by company | |
| 11 Apr 2019 | Classified by FDA | +17 days |
| 17 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Product as listed by the FDA
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Which lots are affected?
Lot 17181491 Exp. Aug. 2021
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.
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 Pravastatin recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20mg, a) recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 80mg, a) recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |