Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nystatin Oral Suspension Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc Due to SubPotent Drug: Low out-of-specification results for assay testing.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PAI Holdings, LLC. dba Pharmaceutical Associates Inc directly.
Affected Products
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Quantity: 7416 bottles
Why Was This Recalled?
SubPotent Drug: Low out-of-specification results for assay testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PAI Holdings, LLC. dba Pharmaceutical Associates Inc
PAI Holdings, LLC. dba Pharmaceutical Associates Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report