Dr. Red: Olanzapine 2.5mg Tablets Recall - Impurity Risk
Dr. Reddy's recalls 2.5mg Olanzapine tablets due to potential impurity affecting safety. Rx-only medication with NDC 55111-163-30. Consumers should contact for details.
Recall notice
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling 2.5mg Olanzapine tablets that may contain harmful impurities. This could pose a safety risk if the tablets degrade over time. Read more at govinfonow.com/recall/42293-dr-red-olanzapine-2-5mg-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42293-dr-red-olanzapine-2-5mg-tablets-recall-impurity-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0468-2017
Cite this page
“Dr. Red: Olanzapine 2.5mg Tablets Recall - Impurity Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42293-dr-red-olanzapine-2-5mg-tablets-recall-impurity-risk. Based on FDA recall #D-0468-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0468-2017%22&limit=1).
Why it’s dangerous
The tablets may contain an impurity called 'Related Substance Compound C' that could degrade over time. This impurity might affect the medication's safety, though the exact risk isn't specified in the recall.
Who’s affected
Prescription medication users who have the 30-count bottle with NDC 55111-163-30. Those with the medication from Dr. Reddy's Laboratories in India are most at risk.
How to tell if you have this one
Check for the 30-count bottle labeled 'Olanzapine tablets, USP, 2.5 mg' with NDC 55111-163-30. The product was made by Dr. Reddy's Laboratories Limited in Bachupally, India.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 55111-163-30 on the bottle label to confirm if it's recalled.
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 terminated this recall 9 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.
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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-0468-2017 (October 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0468-2017 to see it in context.
- Plain-language summary written by qwen3:4b 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.