Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Is Lovastatin recalled?
Not under an active recall.
Lovastatin was recalled 4 times in the past — all now closed. Most recent: Feb 19, 2019.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lovastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lovastatin recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class II · Moderate risk
Lovastatin Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Class II · Moderate risk
Lovastatin
Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: AD28349_1, EXP: 2/28/2014; FLUVASTATIN SODIUM, Capsule, 20 mg, NDC 00078017615, Pedigree: AD73597_7, EXP: 5/31/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: W003247, EXP: 6/17/2014.
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