Mylan Atorvastatin Tablets Recall: Microbial Contamination Risk
Mylan recalls 10mg Atorvastatin Calcium tablets due to potential microbial contamination in non-sterile products. Affected lots may pose a risk of objectionable organisms. Consumers should contact Mylan for details.
Recall notice
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 10 mg Atorvastatin Calcium tablets that may have microbial contamination. This could lead to health risks if the product is used without proper sterilization. Read more at govinfonow.com/recall/41798-mylan-atorvastatin-tablets-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41798-mylan-atorvastatin-tablets-recall-microbial-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0622-2017
Cite this page
“Mylan Atorvastatin Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41798-mylan-atorvastatin-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0622-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0622-2017%22&limit=1).
Why it’s dangerous
The product may contain objectionable organisms due to microbial contamination. This could pose a health risk if the tablets are not properly sterilized before use.
Who’s affected
Prescription users of the 10 mg Atorvastatin Calcium tablets. Those with specific lot numbers are most at risk.
How to tell if you have this one
Check for the lot number 3084288 on the packaging. The product is a 100-count unit dose tablet with NDC 51079-208-20.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 3084288 on the packaging to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years 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-0622-2017 (March 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0622-2017 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.