Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Is Simvastatin recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Simvastatin (41 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Simvastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Simvastatin recalls on record
none so far in 2026; 41 on record, newest first
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10-10mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class III · Low risk
Simvastatin Tablets
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
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.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class II · Moderate risk
Simvastatin
Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014.
Class II · Moderate risk
Simvastatin
Labeling: Label Mixup: SIMVASTATIN, Tablet, 5 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 13668011390, Pedigree: AD65323_10, EXP: 5/29/2014.
Class II · Moderate risk
SIMVASTATIN Tablet
Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, EXP: 6/24/2014.
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