CLASS II Drug recall · Reported 10 Nov 2021 · FDA Enforcement Report
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) recalled
Dr. Reddy's Laboratories is recalling Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) (, distributed nationwide in the US. The recall was initiated on 5 Oct 2021 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-0082-2022
- FDA event ID
- 88798
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Manufacturer
- Dr.Reddys Laboratories Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2021
- FDA classified
- 29 Oct 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 5 Oct 2021 | Recall initiated by company | |
| 29 Oct 2021 | Classified by FDA | +24 days |
| 10 Nov 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Where it was distributed
Nationwide in the US
Questions about this recall
Is Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) ( recalled?
Yes. Dr. Reddy's Laboratories recalled Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) ( on 5 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0082-2022.
Why was it recalled?
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Which lots are affected?
a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Where was it sold?
Nationwide in the US
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
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|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Ezetimibe recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ezetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And Simvastatin | Glenmark Pharmaceuticals Inc., U | 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 |