Atorvastatin Calcium Tablets — Class II drug recall D-0618-2017
Terminated recall by Mylan Pharmaceuticals Inc., reported 2017-04-05, distributed nationwide. Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of obj
| Recall number | D-0618-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2017-03-20 |
| Classified | 2017-03-28 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,233,107 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 00378-3950, 00378-3950-05, 00378-3950-07, 00378-3950-09, 00378-3950-77, 00378-3951, 00378-3951-05, 00378-3951-07, 00378-3951-09, 00378-3951-77, 00378-3952, 00378-3952-05, 00378-3952-07, 00378-3952-09, 00378-3952-77, 00378-3953, 00378-3953-05, 00378-3953-07, 00378-3953-09, 00378-3953-77 |
Product
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0618-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.