Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion
Is Hyaluronidase recalled?
Not under an active recall.
Hyaluronidase was recalled 29 times in the past — all now closed. Most recent: Sep 11, 2024.
Most common reason: Sterility / contamination (28 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hyaluronidase. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hyaluronidase recalls on record
none so far in 2026; 29 on record, newest first
Class II · Moderate risk
Lidocaine HCL / Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
LIDOcaine 2%
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Class II · Moderate risk
S-Hyaluronidase 150u/Ml Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 500u/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Hyaluronidase 175 units/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hyaluronidase 150 units/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hyaluronidase 150 units/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Hyaluronidase
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Hyaluronidase injection solution
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Hyaluronidase base vehicle
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Hyaluron (hyaluronidase)
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I · High risk
Class II · Moderate risk
Hyaluronidase Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Hyaluronidase 150 u/ml PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase/Methylprednisolone Acetate
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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