Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Is Tretinoin recalled?
Not under an active recall.
Tretinoin was recalled 11 times in the past — all now closed. Most recent: Jun 14, 2022.
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tretinoin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tretinoin recalls in 2026
4 initiated in 2026, 11 in total — newest first
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
Class II · Moderate risk
Tretinoin 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
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Tretinoin 0.02% in Oil Free Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TRETINOIN CREAM in all strengths including: 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clindamycin 1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tretinoin or All-Trans Retinoic Acid active pharmaceutical…
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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