CLASS II Drug recall · Reported 12 Feb 2020 · FDA Enforcement Report
Atorvastatin Calcium Tablets, USP, 10 mg* recalled
Graviti Pharmaceuticals Private is recalling Atorvastatin Calcium Tablets, USP, 10 mg*, distributed nationwide in the US. The recall was initiated on 28 Jan 2020 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-0832-2020
- FDA event ID
- 84814
- Recalling firm
- Graviti Pharmaceuticals Private, Medak, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2020
- FDA classified
- 7 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 28 Jan 2020 | Recall initiated by company | |
| 7 Feb 2020 | Classified by FDA | +10 days |
| 12 Feb 2020 | 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
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Product as listed by the FDA
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Which lots are affected?
Lot #: ATA318099C, Exp 12/2020
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 Graviti Pharmaceuticals Private
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride | Graviti Pharmaceuticals Private | Other | Nationwide |
Other Atorvastatin recalls
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin Calcium | Biocon Pharma | Potency & Assay | Nationwide |