Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Fluvastatin recalled?

Not under an active recall. Fluvastatin was recalled 4 times in the past — all now closed. Most recent: May 29, 2014.

Most common reason: Labeling / mix-up (2 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluvastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Fluvastatin recalls on record

none so far in 2026; 4 on record, newest first
Class II · Moderate risk

Fluvastatin Capsules USP

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

Terminated Failed specification Teva Pharmaceuticals USA NDC 0093-7442-56 D-1430-2014
Class II · Moderate risk

Lescol XL (fluvastatin sodium)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9354-07 D-335-2014
Class II · Moderate risk

Fluvastatin

Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-910-2014
Class II · Moderate risk

Fluvastatin Sodium

Labeling: Label Mixup: FLUVASTATIN SODIUM, Capsule, 20 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD73597_1, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-814-2014