Triamcinolone Acetonide Ointment
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Yes — there is an active recall. 15 ongoing FDA recalls mention Triamcinolone (73 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Triamcinolone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Processing Controls
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
CGMP Deviations
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Lack of Processing Controls
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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