CLASS II Drug recall · Reported 5 Apr 2017 · FDA Enforcement Report
Atorvastatin Calcium Tablets, 10 mg* Unit Dose Tablets (10 recalled
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Atorvastatin Calcium Tablets, 10 mg* Unit Dose Tablets (10 x per, distributed nationwide in the US. The recall was initiated on 21 Mar 2017 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-0622-2017
- FDA event ID
- 76802
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Brand
- Atorvastatin Calcium
- Manufacturer
- Mylan Institutional Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2017
- FDA classified
- 28 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cholesterol Medication
Timeline
| 21 Mar 2017 | Recall initiated by company | |
| 28 Mar 2017 | Classified by FDA | +7 days |
| 5 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Which lots are affected?
Lot #: 3084288, Exp. 07/18
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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other 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 |