CLASS II Drug recall · Reported 5 Mar 2014 · FDA Enforcement Report
Atorvastatin Calcium Tablets recalled by Ranbaxy
Ranbaxy is recalling Atorvastatin Calcium Tablets per, distributed nationwide in the US. The recall was initiated on 16 Jan 2014 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-1086-2014
- FDA event ID
- 67485
- Recalling firm
- Ranbaxy, Princeton, NJ
- Brand
- Atorvastatin Calcium
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2014
- FDA classified
- 21 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Cholesterol Medication
Timeline
| 16 Jan 2014 | Recall initiated by company | |
| 21 Feb 2014 | Classified by FDA | +36 days |
| 5 Mar 2014 | Published in enforcement report | +12 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: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Which lots are affected?
2407255, 2407256 Exp. 05/14
Where was it sold?
Nationwide
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 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 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 |
| Drug | CLASS II | Atorvastatin Calcium Tablets, 20 mg 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 |