Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jan 15, 2019 (8 years ago)

Ezetimibe and Simvastatin Tablets 10mg/80 mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10

Affected NDC 43598-0586-10

Compare with the code on your package — it is the most precise check available.

Drug: Simvastatin Category: Cholesterol Medication

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
43598-586-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0389-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Simvastatin recalls

See all
Class III · Low risk

Ezetimibe and Simvastatin Tablets

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Ongoing Impurity / degradation Glenmark Pharmaceuticals Inc., USA NDC 68462-323-90 D-0462-2025
Class II · Moderate risk

Simvastatin USP

CGMP deviations.

Terminated cGMP deviation PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023
Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023

Other recalls by Dr. Reddy's Laboratories, Inc.

All 2019 recalls
Class III · Low risk

Varenicline Tablets

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Ongoing Wrong potency / content Dr. Reddy's Laboratories, Inc. NDC 43598-908-56 D-0219-2026
Class II · Moderate risk

Omeprazole Delayed-release Capsules

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Ongoing Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 82009-022-10 D-0525-2025
Class I · High risk

Levetiracetam 0.75% in Sodium Chloride Injection 1

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Ongoing Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 43598-636-52 D-0365-2025