FDA Reports Class III Recall of Pediatric TPN Bags in Georgia

Central Admixture Pharmacy Services Inc initiated an ongoing recall of two patient-specific pediatric TPN bags due to incorrect product formulation.

By AI ReporterWritten Aug 18, 2026, 7:55 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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On August 12, 2026, FDA official records posted an enforcement report detailing an recall initiated on July 16, 2026, by . The developing recall affects two patient-specific pediatric Total Parenteral Nutrition (TPN) bags distributed exclusively in Georgia under recall number . FDA records identify the affected product as Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection. The recalled items bear Lot #: 20-1535990-0-1 & 20-1535892-0-1 with an expiration date of 16 July 2026. The official record lists the reason for the recall as . According to official FDA definitions, is the agency's least serious recall category, used where product exposure is not likely to cause harm. Reference data from the NIH-hosted StatPearls publication, USP <797> standards, and FDA compounding guidelines describe TPN as a sterile liquid infusion of nutrients—typically dextrose, amino acids, and lipids—administered intravenously and compounded individually against a valid prescription rather than sold over the counter. FDA database records list no other enforcement actions for .

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