Class II · Moderate risk
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%)
Lack of Assurance of Sterility: There are also CGMP Deviations.
Is Tetracaine recalled?
Not under an active recall.
Tetracaine was recalled 38 times in the past — all now closed. Most recent: Nov 9, 2023.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tetracaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tetracaine recalls on record
none so far in 2026; 38 on record, newest first
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
All lidocaine/tetracaine/benzocaine Products
Lack of Processing Controls
Class II · Moderate risk
All tetracaine Products
Lack of Processing Controls
Class II · Moderate risk
Tetracaine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tetracaine
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tetracaine 0.5% ophth.
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
Tetracaine 2%/Pontocaine
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
Tetracaine 2%
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
Tetracaine
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Tetracaine HCL Ophthalmic 0.05% Solution 3 Ml …
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Povidone-Iodine/Lidocaine/Tetracaine 4.6%/4%/0.5% Ophthalmic 30 Ml
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Lidocaine/Tetracaine Ophthalmic 4%/0.5% Solution 10 Ml 15 Ml…
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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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