Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Cholesterol Medication Recalls

Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.

161 recalls in this category, newest first.

Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-080-90 D-0409-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-0040-90 D-0408-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-0020-10 D-0407-2015
Class II · Moderate risk

Simvastatin active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-895-2015
Class II · Moderate risk

Gemfibrozil active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-699-2015
Class II · Moderate risk

Ezetimibe active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-670-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-010-90 D-0246-2015
Class II · Moderate risk

Atorvastatin Calcium Tablets

Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Terminated Particulate / foreign matter Ranbaxy Inc. NDC 63304-827-90 D-1086-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-323-30 D-1312-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-322-30 D-1311-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-321-30 D-1310-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-320-30 D-1309-2014
Class II · Moderate risk

Fenofibrate

Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-909-2014
Class II · Moderate risk

Atorvastatin Calcium

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014; TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-903-2014
Class II · Moderate risk

Atorvastatin Calcium

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD33897_4, EXP: 5/9/2014; FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: W003031, EXP: 2/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-902-2014
Class II · Moderate risk

Atorvastatin Calcium

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD32325_4, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD49582_7, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-901-2014
Class II · Moderate risk

Atorvastatin Calcium

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: AD30180_4, EXP: 5/8/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD49399_4, EXP: 5/16/2014; ASPIRIN, CHEW Tablet, 81 mg, NDC 00536329736, Pedi

Terminated Labeling / mix-up Aidapak Services, LLC D-900-2014
Class II · Moderate risk

Rosuvastatin Calcium

Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC 67877029401, Pedigree: W002577, EXP: 6/3/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD21846_49, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-887-2014
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.

Terminated Labeling / mix-up Aidapak Services, LLC D-879-2014
Class II · Moderate risk

Fenofibrate

Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug: FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD49448_4, EXP: 5/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-860-2014