Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atorvastatin Calcium Tablets Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to Microbial Contamination of Non-Sterile Products: potential of an...

Date: March 21, 2017
Company: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Institutional, Inc. (d.b.a. UDL Laboratories) directly.

Affected Products

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

Quantity: 1,527 cartons

Why Was This Recalled?

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report