Cadila Ondansetron API Recall: Microbial Contamination Risk
Cadila Pharmaceuticals recalls specific batches of ondansetron HCI API due to microbial contamination in non-sterile products. Affected batches expire 08/20 and 09/20. No remedy details provided in official notice.
Recall notice
Microbial Contamination of Non-Sterile Product
Contact the company
What happened, in plain English
Cadila Pharmaceuticals is recalling specific batches of ondansetron HCI API (bulk) because they were contaminated with microbes. This poses a risk to people who might use these products in medical settings. The recall affects only the listed batches and does not include finished medications. Read more at govinfonow.com/recall/42449-cadila-ondansetron-api-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42449-cadila-ondansetron-api-recall-microbial-contamination-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0164-2017
Cite this page
“Cadila Ondansetron API Recall: Microbial Contamination Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42449-cadila-ondansetron-api-recall-microbial-contamination-risk. Based on FDA recall #D-0164-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0164-2017%22&limit=1).
Why it’s dangerous
Microbial contamination in non-sterile products can cause infections if the API is used in medications. Since this is a bulk ingredient, the risk depends on how the contamination spreads during manufacturing and use in final products.
Who’s affected
Healthcare facilities using the recalled API batches for manufacturing are likely affected. Patients receiving medications made from these batches could be at risk if the contamination leads to infection.
How to tell if you have this one
Check for the batch numbers 150N004 (expiring 08/20) or 150N006 (expiring 09/20) on the supplier's records. The product is a bulk API used in manufacturing, not finished medications.
- Brand
Cadila Pharmaceuticals- Category
Drug
What to do — step by step
Check Batch Numbers
Identify if your supplier has the batch numbers 150N004 (expiring 08/20) or 150N006 (expiring 09/20) for ondansetron HCI API.
How this recall unfolded
Recall timeline
FDA terminated this recall 10 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
Is this product safe to use?
The official notice states the product has microbial contamination, so it is not safe for use in medical settings without proper testing.
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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-0164-2017 (September 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0164-2017 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.