CLASS II Drug recall · Reported 30 Jan 2019 · FDA Enforcement Report
Ezetimibe and Simvastatin Tablets 10mg/80 mg recalled
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets 10mg/80 mg, distributed nationwide in the US. The recall was initiated on 15 Jan 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0389-2019
- FDA event ID
- 81936
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2019
- FDA classified
- 22 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 15 Jan 2019 | Recall initiated by company | |
| 22 Jan 2019 | Classified by FDA | +7 days |
| 30 Jan 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Which lots are affected?
Lot #: 43E021 and 43E023, Exp. 01/2020
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ezetimibe recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ezetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And Simvastatin | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ezetimibe and Simvastatin Tablets, 10 mg/80mg recalledEzetimibe And Simvastatin | Golden State Medical Supply | Potency & Assay | AZ, MO |
| Drug | CLASS II | Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalledEzetimibe And Simvastatin | Golden State Medical Supply | Potency & Assay | AZ, MO |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |