Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Is Phenol recalled?
Not under an active recall.
Phenol was recalled 28 times in the past — all now closed. Most recent: Aug 9, 2023.
Most common reason: Sterility / contamination (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Phenol recalls in 2026
2 initiated in 2026, 28 in total — newest first
Class II · Moderate risk
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Phenol 10%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phenol
CGMP Deviations
Class II · Moderate risk
Phenol
Lack of Assurance of Sterility
Class II · Moderate risk
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
S-Phenol 6% Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Dextrose/Glycerin/Phenol 25/25/2.5% Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
C-Phenol/Cottonseed Oil Inj 5%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Phenol 10% Injection
Lack of sterility assurance.
Class II · Moderate risk
Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Phenol 5% and Glycerin Aqueous Solution 10 mL Injection
Lack of Assurance of Sterility
Class I · High risk
Dr. King's SafeCare Rx Allergies: Fragrances & Phenolics
Microbial contamination
Class I · High risk
Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic Allergy Relief
Microbial contamination
Class II · Moderate risk
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Lack of sterility assurance.
Class II · Moderate risk
VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%)
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%)
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Generic Vi Peel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
CGMP Deviations
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class II · Moderate risk
Phenol 6% Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Phenolphthalein 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
Phenol 10% injectable packaged in an amber glass injectable vial
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.
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