Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Is Nystatin recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Nystatin (30 total). Check the affected lots below.
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 on record
none so far in 2026; 30 on record, newest first
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class II · Moderate risk
Nystatin 50
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Nystatin Oral Suspension
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
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