Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Is Atorvastatin recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Atorvastatin (67 total). Check the affected lots below.
Most common reason: Impurity / degradation (14 of these recalls)
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 II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Atorvastatin Calcium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Atorvastatin 20 mg tablets
cGMP Deviations
Class II · Moderate risk
Atorvastatin 10 mg tablets
cGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets
CGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Class III · Low risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class II · Moderate risk
Atorvastatin Calcium Tablet USP 80 mg
Failed Dissolution Specifications
Class III · Low risk
Atorvastatin Calcium tablets
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
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