Class II · Moderate risk
Lidocaine 2.5% & Prilocaine 2.5% Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Prilocaine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Prilocaine (13 total). Check the affected lots below.
Most common reason: cGMP deviation (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Prilocaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Prilocaine recalls on record
none so far in 2026; 13 on record, newest first
Class II · Moderate risk
Lidocaine Prilocaine Cream USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine 2.5% Cream
cGMP Deviations
Class II · Moderate risk
Lidocaine and Prilocaine Cream
cGMP deviations: Temperature abuse
Class II · Moderate risk
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine Cream
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Class II · Moderate risk
Prilocaine HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
LIDOCAINE CREAM in all strengths including: 5%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
LP CREAM (Lidocaine 15%/Prilocaine 5%)
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Prilocaine 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.
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