Unrated Drug recall · FDA · Published May 1, 2024

Dr. Reddy's Sirolimus Tablets 1mg Recall: Impurities May Cause Harm

Dr. Reddy's recalls 100-count Sirolimus 1mg tablets (NDC 55111-653-01) due to failed impurities and degradation. Rx-only tablets distributed in the US from India. No specific remedy stated in recall.

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

🇺🇸 FDA recall #D-0504-2024Drug Dr. Reddy's ›

Recall notice

Failed Impurities/Degradation Specifications

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 is recalling 100-count Sirolimus 1mg tablets (Rx-only) because they may have impurities or degrade, potentially causing harm. This is a medication recall for people with specific medical conditions who require these drugs. Read more at govinfonow.com/recall/32695-dr-reddy-s-sirolimus-tablets-1mg-recall-impurities-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/32695-dr-reddy-s-sirolimus-tablets-1mg-recall-impurities-may-cause · Updated August 17, 2026 · FDA enforcement record: FDA #D-0504-2024

Cite this page

“Dr. Reddy's Sirolimus Tablets 1mg Recall: Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32695-dr-reddy-s-sirolimus-tablets-1mg-recall-impurities-may-cause. Based on FDA recall #D-0504-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0504-2024%22&limit=1).

The FDA announced on May 1, 2024, that Dr. Reddy's Laboratories, Inc. is recalling Sirolimus Tablets 1mg due to failed impurity specifications. The voluntary Class III recall affects 1,176 bottles distributed nationwide.

How to tell if you have it

Brand: Dr. Reddy's
Product: Sirolimus Tablets 1mg
Packaging: 100-count bottle, Rx Only
NDC: 55111-653-01
Lot Code: H2200493
Expiration Date: 6/30/2025
Quantity: 1,176 bottles

The hazard

The recall is due to failed impurities and degradation specifications. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (2025-11-11), Dr. Reddy's Succinylcholine Chloride Injection Recall (2025-09-26), and Dr. Reddy's Omeprazole Capsules Recall (2025-06-30). Other recent recalls of similar products include Macleods Olanzapine Tablets 5mg Recall (2026-08-27), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and Zydus Clomipramine Capsules Recall (2025-10-22).

How to tell if you have this one

Check for the product name 'Sirolimus Tablets 1mg 100-count bottle', Rx-only status, NDC code 55111-653-01, and lot number H2200493. The tablets were made in India and distributed by Dr. Reddy's Laboratories Inc. in Princeton, NJ.

Brand
Dr. Reddy's
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC code 55111-653-01 and lot number H2200493 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 28 days after the firm started it.

May 1, 2024Firm started the recall
May 21, 2024FDA classified it Class III
May 29, 2024Published in FDA’s Enforcement Report

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

Similar recalls

Other Dr. Reddy's recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32695-dr-reddy-s-sirolimus-tablets-1mg-recall-impurities-may-cause">Dr. Reddy's Sirolimus Tablets 1mg Recall: Impurities May Cause Harm (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-0504-2024 (May 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0504-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.