Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Is Atorvastatin recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Atorvastatin (67 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atorvastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Atorvastatin recalls on record
none so far in 2026; 67 on record, newest first
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class III · Low risk
Atorvastatin Calcium Tablets 40 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 20 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 10 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class II · Moderate risk
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class III · Low risk
Atorvastatin Calcium 80 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 40 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 20 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 10 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
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