Unclassified
Nystatin Cream
Failed Stability Specifications
Is Nystatin recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Nystatin (30 total). Check the affected lots below.
Most common reason: Wrong potency / content (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nystatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nystatin recalls in 2026
2 initiated in 2026, 30 in total — newest first
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Ointment
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Nystatin Oral Suspension
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent drug: Out of specification for assay at the 15-month test interval.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Nystatin Oral Suspension
SubPotent Drug: Low out-of-specification results for assay testing.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class III · Low risk
Nystatin and Triamcinolone Acetonide Cream USP100
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III · Low risk
NYSTATIN Oral Suspension
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class III · Low risk
Nystatin Oral Suspension
Resuspension problems: Out of specification for appearance and resuspendability.
Class II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.