IntegraDose ceFAZolin 2g/20mL Recall: Lack of Sterility Risk
IntegraDose recalls specific lots of ceFAZolin 2g/20mL in sterile water for injection due to lack of sterility assurance. Affected products may cause infection if used.
Lower-risk recall
Lack of sterility assurance.
Contact the company
What happened, in plain English
IntegraDose is recalling certain lots of ceFAZolin 2g/20mL in sterile water for injection because the product may not be sterile. Using these products could lead to infections. Read more at govinfonow.com/recall/35850-integradose-cefazolin-2g-20ml-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35850-integradose-cefazolin-2g-20ml-recall-lack-of-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0896-2021
Cite this page
“IntegraDose ceFAZolin 2g/20mL Recall: Lack of Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35850-integradose-cefazolin-2g-20ml-recall-lack-of-sterility-risk. Based on FDA recall #D-0896-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0896-2021%22&limit=1).
Why it’s dangerous
The product lacks sterility assurance, meaning it may contain contaminants that could cause infections when injected. This risk is present in the specific lots listed in the recall.
Who’s affected
Patients who received the recalled lots of ceFAZolin 2g/20mL in sterile water for injection from IntegraDose. Those with medical conditions requiring injections are at higher risk.
How to tell if you have this one
Check the product label for the lot numbers: 20210803CEF-1 through 20210812CEF-1. The expiration dates range from September 17, 2021, to September 26, 2021.
- Brand
IntegraDose- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
NH, MA, MN
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0896-2021 | ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1; Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021 | 2,614 syringes |
| D-0897-2021 | ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1; Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021 | 589 bags |
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall: 20210803CEF-1 through 20210812CEF-1.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “NH, MA, MN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts, Minnesota, New Hampshire.
Recall timeline
FDA terminated this recall 12 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 recall states the product may not be sterile, so it is not safe to use. Affected lots should be discarded.
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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-0896-2021 (September 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0896-2021 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.