Nystatin Oral Suspension (Pharmaceutical Associates) – Resuspension Issues (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Brand
Pharmaceutical Associates Inc
Lot Codes / Batch Numbers
Lot: B5B8 Exp. 07/2019
Products Sold
Lot: B5B8 Exp. 07/2019
Pharmaceutical Associates Inc is recalling Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cup due to Resuspension problems: Out of specification for appearance and resuspendability.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Resuspension problems: Out of specification for appearance and resuspendability.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026