Washington, D.C. — The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of Atorvastatin Calcium tablets, a commonly prescribed cholesterol-lowering medication, after the product failed to meet dissolution standards.
The recall involves multiple lots of Atorvastatin Calcium Tablets USP, manufactured by Ascend Laboratories, LLC, with approximately 141,984 bottles affected across the United States.
Affected Products
According to the FDA’s enforcement report, the recall was initiated due to “failed dissolution specifications,” meaning that the tablets may not properly dissolve in the body — a defect that could potentially reduce the drug’s effectiveness in managing cholesterol levels.
The recall includes various dosages and packaging counts, with the following lot numbers and expiration dates:
FDA Recall Notice: Atorvastatin Calcium Tablets (Ascend Laboratories, LLC)
Reason for Recall: Failed dissolution specifications
Total Bottles Affected: 141,984
Source: FDA Enforcement Report: Atorvastatin Calcium Tablets
| Product Description | Pill Count | Lot Numbers | Expiration Dates |
|---|---|---|---|
| Atorvastatin Calcium Tablets USP, 10 mg | 90-count; 500-count; 1000-count | 25141249; 24144938; 24144868; 24144867; 24144458; 24143994; 24142987; 24143316 | Feb. 2027; Nov. 2026; Sept. 2026; July 2026 |
| Atorvastatin Calcium Tablets USP, 20 mg, Rx Only | 90-count; 500-count; 1000-count | 25140150; 25140173; 25140172; 24144720; 24144798; 24144692; 24143755; 24143913; 24143754; 24143047; 24142936 | Dec. 2026; Nov. 2026; Oct. 2026; Aug. 2026; July 2026; June 2026 |
| Atorvastatin Calcium Tablets USP, 40 mg, Rx Only | 90-count; 500-count; 1000-count | 25140933; 25140477; 24144254; 24144163; 24143995 | Feb. 2027; Dec. 2026; Oct. 2026; Sept. 2026 |
| Atorvastatin Calcium Tablets USP, 80 mg, Rx Only | 90-count; 500-count | 25140249; 25140247; 24144999; 24144942; 24144845; 24144713; 24144652; 24143898; 24143412; 24143582 | Dec. 2026; Nov. 2026; Oct. 2026 |
Recall Classification and Consumer Guidance
The FDA has classified the recall as Class II, which indicates that the affected product may cause temporary or medically reversible health issues, but is unlikely to result in serious injury or death.
Patients are urged to check the label on their prescription bottles and compare the lot and expiration details with those listed above. If their medication matches a recalled batch, they should contact their pharmacist or healthcare provider immediately to arrange a replacement or refund.
Manufacturer and Safety Information
Ascend Laboratories, LLC initiated the recall voluntarily under FDA supervision. As of this report, there have been no confirmed injuries or adverse events associated with the affected lots.
