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 Lack of CGMP: This recall is being carried...
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, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Quantity: a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Why Was This Recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
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.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report