Zydus Fulvestrant Injection Recall: Impurities May Cause Harm
Zydus Pharmaceuticals recalls Fulvestrant injection due to failed impurities and degradation specifications. This prescription drug, sold in single-dose prefilled syringes, may pose health risks if used improperly.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling Fulvestrant injection 250mg/5mL (50 mg/mL) products that contain two single-dose prefilled syringes. The recall is due to potential impurities and degradation in the drug, which could cause health risks if used. Read more at govinfonow.com/recall/34405-zydus-fulvestrant-injection-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/34405-zydus-fulvestrant-injection-recall-impurities-may-cause-harm · Updated August 18, 2026 · FDA enforcement record: FDA #D-1351-2022
Cite this page
“Zydus Fulvestrant Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34405-zydus-fulvestrant-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-1351-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1351-2022%22&limit=1).
Why it’s dangerous
The product failed impurities and degradation specifications, meaning the drug may contain harmful substances or break down in a way that could cause health issues. This is a prescription-only medication, so it's used under medical supervision.
Who’s affected
Prescription patients who have received this specific Fulvestrant injection product are affected. Those with a prescription for this medication and the listed lot number are most at risk.
How to tell if you have this one
Check for the product name 'Fulvestrant Injection 250mg/5mL (50 mg/mL)' with two single-dose prefilled syringes. The lot number B200076 and expiration date of January 31, 2024, are specific identifiers for this recall.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number B200076 and expiration date of January 31, 2024 on the product label.
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 23 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.
Similar recalls
Other Zydus Pharmaceuticals recalls
Latest drug recalls
Keep exploring
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-1351-2022 (July 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1351-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.