Heritage Pharmaceuticals recalls Cidofovir injection vials due to dried powder on bottles
Heritage Pharmaceuticals recalls Cidofovir injection vials (5mL) manufactured by Emcure Pharmaceuticals in India due to complaints of dried powder on bottle exteriors. This may affect sterility.
Lower-risk recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Contact the company
What happened, in plain English
Heritage Pharmaceuticals is recalling Cidofovir injection vials because complaints reported dried powder on the outside of the bottles. This could mean the product isn't sterile, which is dangerous for medical use. Read more at govinfonow.com/recall/39504-heritage-pharmaceuticals-recalls-cidofovir-injection-vials-due-to-dried-powder.
Source Summary by GovInfoNow · govinfonow.com/recall/39504-heritage-pharmaceuticals-recalls-cidofovir-injection-vials-due-to-dried-powder · Updated October 6, 2026 · FDA enforcement record: FDA #D-0094-2019
Cite this page
“Heritage Pharmaceuticals recalls Cidofovir injection vials due to dried powder on bottles.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39504-heritage-pharmaceuticals-recalls-cidofovir-injection-vials-due-to-dried-powder. Based on FDA recall #D-0094-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0094-2019%22&limit=1).
Why it’s dangerous
Dried powder on the bottle exterior may indicate contamination, which could lead to infections if the injection is used. This is a sterility issue that affects medical safety.
Who’s affected
People who have prescription Cidofovir injections from this manufacturer. Patients receiving this medication for serious conditions like certain cancers or viral infections are most at risk.
How to tell if you have this one
Check for vials labeled 'Cidofovir injection 375 mg/mL (75 mg/mL) 5 mL vials, Rx Only' made by Emcure Pharmaceuticals in India. Look for the UPC 323155216388 or NDC 23155-216-31.
- Brand
Heritage Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for dried powder on the outside of the bottle. If present, do not use the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.5 years 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.
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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-0094-2019 (October 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0094-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.