Heritage Pharmaceuticals recalls Cidofovir injection due to dried powder on bottles
Heritage Pharmaceuticals recalls Cidofovir injection vials (NDC 23155-0216-31) because dried powder on the outside of bottles may indicate lack of sterility. This is a prescription-only medication.
Lower-risk recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Contact the company
What happened, in plain English
Heritage Pharmaceuticals is recalling Cidofovir injection vials that may have dried powder on the outside of the bottle. This could mean the product isn't sterile, which is dangerous for patients using it for treatment. Read more at govinfonow.com/recall/39257-heritage-pharmaceuticals-recalls-cidofovir-injection-due-to-dried-powder-on.
Source Summary by GovInfoNow · govinfonow.com/recall/39257-heritage-pharmaceuticals-recalls-cidofovir-injection-due-to-dried-powder-on · Updated October 5, 2026 · FDA enforcement record: FDA #D-0352-2019
Cite this page
“Heritage Pharmaceuticals recalls Cidofovir injection due to dried powder on bottles.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39257-heritage-pharmaceuticals-recalls-cidofovir-injection-due-to-dried-powder-on. Based on FDA recall #D-0352-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0352-2019%22&limit=1).
Why it’s dangerous
Dried powder on the outside of the bottle suggests the product may not be sterile. This could lead to infections or other complications if the medication is used without proper sterility.
Who’s affected
Prescription patients using Cidofovir injection for treatment. Those with the specific vial lot numbers (VCIA082, VCIA083, VCIA084) are most at risk.
How to tell if you have this one
Check for vials labeled 'Cidofovir Injection 375mg/5mL (75mg/mL)' with lot numbers VCIA082, VCIA083, or VCIA084. These vials were manufactured by Emcure Pharmaceuticals Ltd. in Pune, India and expire by May 2020 or June 2020.
- Brand
Heritage Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Lot Number
Look for lot numbers VCIA082, VCIA083, or VCIA084 on the vial 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 2.1 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.
Questions people ask
What should I do if I have this product?
Contact Heritage Pharmaceuticals at 1-800-231-5502 to get a replacement vial if you have the recalled lot numbers.
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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-0352-2019 (January 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0352-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.