Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Is Lidocaine recalled?
Yes — there is an active recall. 61 ongoing FDA recalls mention Lidocaine (366 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lidocaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lidocaine recalls on record
none so far in 2026; 366 on record, newest first
Class I · High risk
del Nido Cardioplegia with Lidocaine 1052.8 ml
Non Sterility; microbial contamination identified as Aspergillus species
Class II · Moderate risk
B-Complex/Adenosine Inj sol
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Class II · Moderate risk
Lidocaine 4% Urethral Gel
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
Lidocaine/Sodium Chl* 0.4 %/18 % Injectable
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
Combo Eye Gel
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 I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Class II · Moderate risk
5% Lidocaine HCl and 7.5% Dextrose Injection
Presence of Particulate Matter; report of visible particulates in the glass ampule
Class II · Moderate risk
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Lidocaine 1% PF Sterile Injection
Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Class II · Moderate risk
Lipo-Injection w/ Lidocaine
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Lidocaine Hydrochloride 2% and Epinephrine 1:100
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Class II · Moderate risk
Pumice/Lidocaine HCL 1.5%/1% Inj Susp
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Mic-Carn + B6/B12/Lidocaine 25/50/50/175mcg/1/0.1mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Lidocaine Mdv 1% Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Estradiol Valerate W/ Lidocaine 1% 40 Mg/Ml Oil Inj Soln
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
B-Complex/Lidocaine 2% Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
B-12/Lidocaine 25/10mg/Ml
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Testosterone Cypionate w/lidocaine 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Methylprednisolone 80mg w/lidocaine 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Methylprednisolone 40mg w/lidocaine 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Methylprednisolone 40 w/lidocaine 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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