FDA Announces Nationwide Recall of Cholesterol Medication—More Than 140,000 Bottles Affected
More than 140,000 bottles of a prescription cholesterol medication have been recalled due to “failed dissolution specifications,” the Food and Drug Administration announced earlier this month.
Ascend Laboratories of New Jersey recalled certain bottles of Atorvastatin Calcium tablets, a generic version of Lipitor, sold nationwide. The recall was announced on Sept. 19 and given a Class II risk level on Oct. 10.
The Class II classification indicates that the recalled medication “may cause temporary or medically reversible adverse health consequences,” but the risk of serious health consequences is low.
The recall affects at least 141,984 bottles of Atorvastatin Calcium tablets, a type of statin used to lower the amount of cholesterol in a person’s blood to prevent stroke, heart attack, and chest pain.
See the entire list of recalled medications below, including dosages, bottle sizes, and expiration dates:
| Product Description | Bottle Size | Lot Numbers | Expiration Dates |
| Atorvastatin Calcium Tablets USP, 10 mg | 90-count, 500-count, and 1000-count bottles | 25141249, 24144938, 24144868, 24144867, 24144458, 24143994, 24142987, 24143316, | Feb. 2027, Nov. 2026, Sep. 2026, July 2026 |
| Atorvastatin Calcium Tablets USP, 40 mg | 90-count, 500-count, and 1000-count bottles | 25140933, 25140477, 24144254, 24144163, 24143995 | Feb. 2027, Dec. 2026, Oct. 2026, Sep. 2026, |
| Atorvastatin Calcium Tablets USP, 20 mg | 90-count, 500-count, and 1000-count bottles | 25140150, 25140173, 25140172, 24144720, 24144798, 24144692, 24143755, 24143913, 24143754, 24143047, 24142936 | Dec. 2026, Nov. 2026, Oct. 2026, Aug. 2026, June 2026, July 2026 |
| Atorvastatin Calcium Tablets USP, 80 mg | 90-count and 500-count bottles | 25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, 24143582 | Dec. 2026, Nov. 2026, Oct. 2026, Aug. 2026, |
Ascent Laboratories recalled the medication due to “failed dissolution specifications,” meaning the drug did not dissolve as expected in laboratory settings, which could make it less effective.
The recalling firm did not issue a press release for this recall, so there are no specific instructions for medications users.
Your best bet is to check your medications at home, and if you have any bottles affected by the recall, don’t take them. Instead, call your healthcare provider or a pharmacy for a replacement bottle or a refund.
