Mylan Atorvastatin 10mg Tablets Recall: Microbial Contamination Risk
Mylan recalls 10mg Atorvastatin Calcium Tablets with potential microbial contamination. Affected lots have specific NDC numbers and expiration dates. Consumers should check their product details and contact Mylan for guidance.
Lower-risk recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Contact the company
What happened, in plain English
Mylan is recalling 10mg Atorvastatin Calcium Tablets due to potential microbial contamination. This could lead to an elevated bioburden with objectionable organisms, though the risk is not specified as causing serious injury in normal use. Read more at govinfonow.com/recall/41800-mylan-atorvastatin-10mg-tablets-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41800-mylan-atorvastatin-10mg-tablets-recall-microbial-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0618-2017
Cite this page
“Mylan Atorvastatin 10mg Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41800-mylan-atorvastatin-10mg-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0618-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0618-2017%22&limit=1).
Why it’s dangerous
The tablets may contain objectionable organisms, which could lead to an elevated bioburden. This microbial contamination might cause health issues, but the recall does not specify serious injury risks in normal use.
Who’s affected
People who have the recalled Atorvastatin Calcium Tablets (10mg) with specific NDC numbers and expiration dates listed in the recall. Those taking this medication for cholesterol management are most at risk.
How to tell if you have this one
Check the product label for the NDC numbers: 0378-3950-05, 0378-3950-07, 0378-3950-77, or 0378-3950-09. Also look for expiration dates matching the listed lots (e.g., Exp 05/18, Exp 06/18).
- Brand
Mylan- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA and Puerto Rico- NDC
0378-3950-77, 0378-3950-05, 0378-3950-09, 0378-3950-07, 0378-3951-77, 0378-3951-05, 0378-3951-09, 0378-3951-07, 0378-3952-77, 0378-3952-05, 0378-3952-09, 0378-3952-07, 0378-3953-77, 0378-3953-05, 0378-3953-09, 0378-3953-07
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0618-2017 | 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.; Lot #: a) 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18; b) 3073773, Exp 01/18; 2007445, Exp 09/18; c) 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18; d) 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18 | 1,233,107 bottles |
| D-0619-2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 3073776, Exp 01/18; 3073777, 3074909, Exp 02/18; 3075564, 3075565, Exp 03/18; 2007338, Exp 08/18; b) 3070838, Exp 10/17; 3073775, Exp 01/18; 3074908, 3074909, Exp 02/18; 3075564, Exp 03/18; 2007224, 3075887, Exp 06/18; 2007337, 2007338, Exp 08/18 | 299,112 bottles |
| D-0620-2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 3073779, 3073780, Exp 02/18; 3074910, Exp 03/18; 3075568, Exp 04/18; 3075889, 3075890, Exp 06/18; 2007339, 2007340, Exp 08/18; 3079881, 3079882, Exp 10/18; b) 3070839, Exp 10/17; 3073778, 3073779, Exp 02/18; 3075566, 3075567, Exp 04/18; 3075890, 2007225, Exp 06/18; 2007340, Exp 08/18; 3079880, 3079881, Exp 10/18 | 444,201 bottles |
| D-0621-2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 3073782, 3073783, Exp 02/18; 3074915, 3074916, 3074917, Exp 03/18; 3074918, 3075572, Exp 04/18; 3075573, 3075574, Exp 05/18; 2007226, 3075894, Exp 06/18; 2007344, 2007345, 2007346, Exp 08/18; 2007451, 2007452, 2007453, 2007454, Exp 09/18; b) 3070840, Exp 10/17; 3073781, 3074911, Exp 02/18; 3074912, 3074913, 3074914, Exp 03/18; 3075570, 3075571, Exp 04/18; 3075892, Exp 05/18; 3075893, Exp 06/18; 2007341, 2007342, 2007343, 2007347, Exp 08/18; 2007456, Exp 10/18 | 452,269 bottles |
What to do — step by step
Check Product Details
Look for the NDC numbers and expiration dates listed in the recall to confirm if your tablets are affected.
Contact Mylan
Reach out to Mylan Pharmaceuticals Inc. for further guidance on the recall and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0618-2017 (March 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0618-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.