Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity Issues
Dr. Reddy's recalls specific lots of 1 mg Sirolimus tablets due to failed impurity specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Contact the company
What happened, in plain English
Dr. Reddy's Laboratories, Inc. is recalling specific lots of Sirolimus Tablets, 1 mg, in 100-count bottles. The recall was initiated because the product failed quality specifications for an impurity called secorapamycin. This means the drug may contain higher-than-allowed levels of this degradation product. Read more at govinfonow.com/recall/42592-dr-reddy-s-recalls-sirolimus-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42592-dr-reddy-s-recalls-sirolimus-tablets-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1063-2016
Cite this page
“Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42592-dr-reddy-s-recalls-sirolimus-tablets-due-to-impurity-issues. Based on FDA recall #D-1063-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1063-2016%22&limit=1).
Why it’s dangerous
The tablets contain out-of-specification levels of the impurity secorapamycin. While the exact health impact is not detailed in this record, failing impurity standards means the drug's purity does not meet regulatory requirements for safety and quality.
Who’s affected
Patients currently taking Sirolimus prescribed by a doctor are affected. Specifically, those who have bottles manufactured by Dr. Reddy's Laboratories Limited in India with the listed lot numbers and expiration dates.
How to tell if you have this one
Check your medication bottle for NDC 55111-653-01. Verify if it was manufactured by Dr. Reddy's Laboratories Limited in Visakhapatnam, India. Look for one of the following lot numbers: H400044, H400045 (Exp 07/16); H400048 (Exp 08/16); H400055 (Exp 10/16); or H400070, H400071, H400073, H400074 (Exp 11/16).
- Brand
Dr. Reddy's Laboratories- Category
Drug
What to do — step by step
Contact Your Doctor
Speak with your healthcare provider to discuss whether you should continue taking this medication or switch to a different supplier.
Do Not Dispose of Medication
The record does not state that you should discard the tablets, so do not throw them away without professional advice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the expiration date for these recalled tablets?
Lots H400044 and H400045 expire in July 2016; H400048 expires in August 2016; H400055 expires in October 2016; and lots H400070, H400071, H400073, and H400074 expire in November 2016.
How many bottles are being recalled?
A total of 9,330 bottles are included in this recall.
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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-1063-2016 (June 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1063-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.