Genzyme Recalls Lumizyme Due to Labeling Errors
Genzyme recalls specific lots of Lumizyme (alglucosidase alpha) because the labeling has incorrect or missing lot and expiration dates.
Recall notice
Labeling: Incorrect or Missing Lot and/or Exp Date
Contact the company
What happened, in plain English
Genzyme Corporation is recalling a small quantity of Lumizyme, an intravenous infusion drug used for treatment. The recall was issued because the product's labeling contains incorrect or missing lot numbers and/or expiration dates. This issue affects only 24 vials distributed in Tennessee. Read more at govinfonow.com/recall/43345-genzyme-recalls-lumizyme-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/43345-genzyme-recalls-lumizyme-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0799-2016
Cite this page
“Genzyme Recalls Lumizyme Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43345-genzyme-recalls-lumizyme-due-to-labeling-errors. Based on FDA recall #D-0799-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0799-2016%22&limit=1).
Why it’s dangerous
The primary hazard is that the labeling does not accurately identify the product's manufacturing lot or expiration date. This makes it difficult to verify the drug's identity and potency, which could lead to improper use or administration of an expired product.
Who’s affected
Patients in Tennessee who received Lumizyme from the specific recalled lots are affected. Healthcare providers administering this drug to these patients are also impacted.
How to tell if you have this one
Check if you have Lumizyme (alglucosidase alpha), 50 mg/vial, manufactured by Genzyme Corporation in Cambridge, MA. Look for NDC 58468-0160-1 and Lot # C5370C02 with an expiration date of 02/18.
- Brand
Genzyme- Category
Drug
Where it went and when
Where it was distributed
Distributed in Tennessee.
FDA distribution: “TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0799-2016 (December 8, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0799-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.