Dr. Reddy's Ondansetron 4mg Recall: Impurity Issues
Dr. Reddy's recalls specific lots of Ondansetron Tablets USP 4 mg due to failed impurity specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications; 12 month stability time point
Contact the company
What happened, in plain English
Dr. Reddy's Laboratories, Inc. is recalling Ondansetron Tablets USP, 4 mg, in 30-count bottles because they failed impurity and degradation specifications at the 12-month stability time point. The affected product was distributed nationwide. The recall record does not specify a remedy or current action for consumers. Read more at govinfonow.com/recall/43024-dr-reddy-s-ondansetron-4mg-recall-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/43024-dr-reddy-s-ondansetron-4mg-recall-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0841-2016
Cite this page
“Dr. Reddy's Ondansetron 4mg Recall: Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43024-dr-reddy-s-ondansetron-4mg-recall-impurity-issues. Based on FDA recall #D-0841-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0841-2016%22&limit=1).
Why it’s dangerous
The tablets failed to meet specifications for impurities or degradation after 12 months of stability testing. This means the chemical composition of the drug may have changed over time, potentially affecting its safety or effectiveness, though the specific health consequences are not detailed in this record.
Who’s affected
Patients who have been prescribed Ondansetron Tablets USP, 4 mg by Dr. Reddy's Laboratories, Inc. are affected. Specifically, individuals possessing bottles with NDC 56111-153-30 and Lot number C500691 expiring in 12/2016 are at risk.
How to tell if you have this one
Look for 30-count bottles of Ondansetron Tablets USP, 4 mg, Rx only, manufactured by Dr. Reddy's Laboratories, Inc. in Bachupally, India. The specific recalled item has NDC 56111-153-30 and Lot number C500691 with an expiration date of 12/2016.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches NDC 56111-153-30 and Lot number C500691 expiring in 12/2016.
Contact Your Pharmacist
Since the remedy is not stated in this record, consult your healthcare provider or pharmacist for instructions on what to do with these specific tablets.
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 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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 NDC number for the affected tablets?
The National Drug Code (NDC) is 56111-153-30.
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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-0841-2016 (March 30, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0841-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.