CLASS II Drug recall · Reported 5 Dec 2012 · FDA Enforcement Report
Atorvastatin Calcium Tablets, 10 mg recalled by Ranbaxy
Ranbaxy is recalling Atorvastatin Calcium Tablets, 10 mg per, distributed nationwide in the US. The recall was initiated on 9 Nov 2012 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-070-2013
- FDA event ID
- 63759
- Recalling firm
- Ranbaxy, Princeton, NJ
- Brand
- Atorvastatin Calcium
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2012
- FDA classified
- 29 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Cholesterol Medication
Timeline
| 9 Nov 2012 | Recall initiated by company | |
| 29 Nov 2012 | Classified by FDA | +20 days |
| 5 Dec 2012 | 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 Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product as listed by the FDA
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90
Where it was distributed
Nationwide and PR
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Which lots are affected?
Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Where was it sold?
Nationwide 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 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 products in this recall event
2 other products · FDA event 63759| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atorvastatin Calcium Tablets, 20 mg recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Particulate Matter | Nationwide | |
| CLASS II | Atorvastatin Calcium Tablets, 40 mg, a) per, b) recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Particulate Matter | Nationwide |
More recalls from Ranbaxy
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Absorica (isotretinoin) Capsules, 25 mg recalled by RanbaxyAbsorica Ld | Ranbaxy | Labeling Errors | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Packaging Defects | Nationwide |
| Drug | CLASS III | Lac-Hydrin (ammonium lactate) Cream recalled by Ranbaxy | Ranbaxy | Packaging Defects | Nationwide |
| Drug | CLASS III | Lac-Hydrin (ammonium lactate) Lotion recalled by Ranbaxy | Ranbaxy | Packaging Defects | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, 40 mg, a) per, b) recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Particulate Matter | 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 |