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Unrated Food recall · FDA · Published January 29, 2019

Prolact CR Human Milk Caloric Fortifier Recall: Unreleased Shipment Risk

Prolacta Bioscience recalls human milk caloric fortifier bottles due to unconfirmed shipment issues. Affected products were shipped under quarantine pending investigation. Consumers should check product codes and contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #F-1099-2019FoodProlacta Bioscience ›
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Contact the company

Recalling firmProlacta Bioscience1800 Highland Ave · Duarte, CA 91010-2837
✎ GovInfoNow plain-language explainer

Prolacta Bioscience is recalling human milk caloric fortifier bottles that were shipped under quarantine. This recall is due to unconfirmed shipment issues that could pose a risk to premature infants. The product is intended for use with human milk in premature or low birth weight infants. Read more at govinfonow.com/recall/17744-prolact-cr-human-milk-caloric-fortifier-recall-unreleased-shipment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/17744-prolact-cr-human-milk-caloric-fortifier-recall-unreleased-shipment-risk · Updated October 5, 2026 · FDA enforcement record: FDA #F-1099-2019

Cite this page

“Prolact CR Human Milk Caloric Fortifier Recall: Unreleased Shipment Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/17744-prolact-cr-human-milk-caloric-fortifier-recall-unreleased-shipment-risk. Based on FDA recall #F-1099-2019 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-1099-2019%22&limit=1).

The Food and Drug Administration announced on Jan. 29, 2019, that Prolacta Bioscience voluntarily recalled Prolact CR; Human Milk Caloric Fortifier because the shipped lot was un released and under quarantine pending investigation closures.

How to tell if you have it

  • Brand: Prolacta Bioscience
  • Product: Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized)
  • Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles
  • Lot: CC101806USA
  • Expiration: 11/19/20

The hazard

The shipped lot was un released and under quarantine pending investigation closures.

Context

GovInfoNow's records show Prolacta Bioscience has had other recent recalls of similar products, including Pasteurized Donor Human Milk in 4oz Bottles with Foreign Object Risk (2025-11-11), a2 Platinum Premium Infant Formula Recall: Possible Cereulide Toxin Contamination (2026-05-01), and UC Health Recalls Pasteurized Donor Human Milk for Plastic Contamination (2026-05-22).

How to tell if you have this one

Check for product code 94000-10 on 4-10 mL (0.3 fl. oz) bottles. The product was manufactured by Prolacta Bioscience in City of Industry, CA with lot number CC101806USA and expires November 19, 2020.

  • Brand
    Prolacta Bioscience
  • Category
    Food
Based on the official FDA remedy

What to do — step by step

  1. Check Product Code

    Look for product code 94000-10 on the bottle label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in North Carolina.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “One customer in NC” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: North Carolina.

Recall timeline

FDA terminated this recall 34 days after the firm started it.

1. Firm started the recall: Jan 29, 201912. FDA classified it Class III: Feb 27, 201923. FDA terminated the recall: Mar 4, 201934. Published in FDA’s Enforcement Report: Mar 6, 201942019
  1. Firm started the recall
  2. FDA classified it Class III
  3. FDA terminated the recall
  4. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Recall: Pasteurized Donor Human Milk in 4oz Bottles with Foreign Object Risk
The New York Milk Banka2 Platinum Premium Infant Formula Recall: Possible Cereulide Toxin Contamination
a2 Milk CompanyUC Health Recalls Pasteurized Donor Human Milk for Plastic Contamination
UC Health Milk BankMenopause Bully 16oz and 32oz Food Recall: Under-processed Risk
Liquid Blenz CorpRecall: Mothers' Milk Bank Donor Human Milk Due to Contamination
Mothers' Milk Bank of Louisiana

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #F-1099-2019 (January 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-1099-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA