CLASS III Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Atorvastatin Calcium Tablets, USP 40 mg* recalled by Apotex
Apotex is recalling Atorvastatin Calcium Tablets, USP 40 mg*, distributed in Illinois, Mississippi, New Jersey, Ohio, Texas. The recall was initiated on 22 Oct 2019 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-0153-2020
- FDA event ID
- 84107
- Recalling firm
- Apotex, North York
- Brand
- Atorvastatin Calcium
- Manufacturer
- Apotex Corp.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Oct 2019
- FDA classified
- 28 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 22 Oct 2019 | Recall initiated by company | |
| 28 Oct 2019 | Classified by FDA | +6 days |
| 6 Nov 2019 | Published in enforcement report | +9 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: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Product as listed by the FDA
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Where it was distributed
IL, MS, NJ, OH, TX
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Which lots are affected?
Lot: RC5439 Exp. 03/2022
Where was it sold?
IL, MS, NJ, OH, TX
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 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.
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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 |