Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nystatin Oral Suspension Recalled by Pharmaceutical Associates Inc Due to Subpotent: Out of specification for assay at the...
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 Pharmaceutical Associates Inc directly.
Affected Products
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Quantity: 6288 16 oz bottles
Why Was This Recalled?
Subpotent: Out of specification for assay at the 12-month time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pharmaceutical Associates Inc
Pharmaceutical Associates Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report