Unrated Drug recall · FDA · Published October 5, 2021

Dr. Reddy's Ezetimibe-Simvastatin Tablets Recall: Failed Excipient Risk

Dr. Reddy's Ezetimibe and Simvastatin 10mg/40mg tablets (30 or 90 count) recalled due to excipient conductivity issues. Rx-only product with NDC codes 43598-743-30 and 43598-743-90. No remedy specified in official recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0084-2022Drug Dr. Reddy's ›

Recall notice

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Take action

Contact the company

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623

✎ GovInfoNow plain-language explainer

Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg) are being recalled because the manufacturing process used an excipient that failed conductivity tests. This could potentially affect the medication's safety and effectiveness, though the recall does not specify a remedy. Read more at govinfonow.com/recall/35800-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-failed-excipient-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35800-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-failed-excipient-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0084-2022

Cite this page

“Dr. Reddy's Ezetimibe-Simvastatin Tablets Recall: Failed Excipient Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35800-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-failed-excipient-risk. Based on FDA recall #D-0084-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0084-2022%22&limit=1).

The FDA announced on 2021-10-05 that Dr. Reddy's Laboratories, Inc. voluntarily recalled Dr. Reddy's Ezetimibe and Simvastatin Tablets due to failed excipient specifications. The recall affects specific lots of the 10 mg/40 mg tablets distributed nationwide.

How to tell if you have it

Brand: Dr. Reddy's
Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg
NDC 43598-743-30 (30 count), Lot L100158, exp 12/2022
NDC 43598-743-90 (90 count), Lot L100159, exp 12/2022

The hazard

The product was manufactured using an excipient found to be out of specification for conductivity. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Recent brand recalls include the 2025-11-11 Varenicline Tablets recall for subpotent drug risk and the 2025-09-26 Succinylcholine Chloride Injection recall for stability testing issues. Other recent recalls of similar products include Sun Pharmaceutical Lisdexamfetamine Capsules Recall (2025-10-28), Teva Metoprolol Succinate Tablets Recall (2026-01-29), and Safecor Health Fluphenazine Elixir Recall (2026-08-13).

How to tell if you have this one

Check for bottles labeled 'Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg' with NDC codes 43598-743-30 (30 count) or 43598-743-90 (90 count). These are prescription-only products with expiration dates of December 2022.

Brand
Dr. Reddy's
Category
Drug

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide in the US
NDC
43598-742-30, 43598-742-90, 43598-742-10, 43598-744-30, 43598-744-90, 43598-744-10, 43598-743-30, 43598-743-90, 43598-743-05, 43598-745-30, 43598-745-90, 43598-745-05

Recall number	Product, codes & lots	Quantity
D-0081-2022	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) 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, , packaged in bottles.; a) L100256, exp 01/2023; b) L100257, exp 01/2023	a) 776 bottles, b) 84 bottles
D-0082-2022	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; a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023	a) 30,839 bottles, b) 3,830 bottles
D-0083-2022	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) 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; a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023	a) 3,444 bottles b) 469 bottles c) 142 bottles
D-0084-2022	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) 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; a) L100158, exp 12/2022 b) L100159, exp 12/2022	a) 11,590 bottles b) 3,585 bottles
D-0085-2022	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count 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 NDC 43598-743-05; L100208, exp 01/2023	696 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your prescription contains the specific NDC codes 43598-743-30 or 43598-743-90 for the 30-count or 90-count tablets.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Oct 5, 2021Firm started the recall
Oct 29, 2021FDA classified it Class II
Nov 10, 2021Published in FDA’s Enforcement Report
Feb 16, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the expiration date for these tablets?

The tablets have expiration dates of December 2022 (as indicated by lot numbers L100158 and L100159).

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Link to this recall

<a href="https://govinfonow.com/recall/35800-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-failed-excipient-risk">Dr. Reddy's Ezetimibe-Simvastatin Tablets Recall: Failed Excipient Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0084-2022 (October 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0084-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.