Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate. Manufactured by: Prolacta Bioscience, Inc., City of Industry, CA 91746

Prolacta Bioscience recalled Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized) in a Class III action, the FDA tier used when a product is unlikely to cause adverse health effects, typically for labeling or minor regulatory issues on Jan 29, 2019.

The FDA-published reason for this recall is: "Shipped lot was un released and under quarantine pending investigation closures."

The product reached multiple states, recorded by the FDA as "One customer in NC." A multi-state footprint means the same lot can surface in households far from the producer. The recalling firm is based in Duarte, CA. The recall covers 16 bottles (1 case with 4 individual bottles per carton) of product. The FDA has Terminated this recall (first reported Mar 6, 2019), its final lifecycle state, indicating the agency considers the corrective action resolved. The historical record remains useful for tracking a brand's recall pattern over time.