Hyaluronidase recalls

The FDA has published 9 recalls involving Hyaluronidase since 2012. The latest was reported on 18 Dec 2024. Most were for sterility. Franck's Lab Inc., d.b.a. Franck's Compounding Lab has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls9since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 1 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 9 100%Class III 0 0%

Why hyaluronidase is recalled

Sterility889%
Manufacturing (CGMP) Deviations111%

Companies

By year

2024111%
2015333%
2014111%
2013111%
2012333%

All hyaluronidase recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
18 Dec 2024Drug	CLASS II	Hylenex recombinant (hyaluronidase) injection recalledHylenex Recombinant	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	VA
23 Sep 2015Drug	CLASS II	Hyaluronidase/ml Injection, ml, Sterile, Preserved recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Hyaluronidase/ml Injection, ml, Sterile, Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Hyaluronidase/ml Injection, ml, Sterile, Preserved recalled	The Compounding Pharmacy of America	Sterility	Nationwide
12 Nov 2014Drug	CLASS II	Hyaluronidase, 240 u/mL, injectable glass vial, RX recalled	Oregon Compounding Centers	Sterility	OR, WA
22 May 2013Drug	CLASS II	Hyaluronidase Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Hyaluronidase/methylprednisolone Acetate recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Hyaluronidase / Lidocaine / Bupicavaine 7.1u/9.5mg/3.5mg/ML recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Hyaluronidase / Lidocaine 7.1u/9.5mg/ML Injectable recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Hyaluronidase?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.