Severity
Low
LowClass IIITerminated
FDA Food recall · Reported March 6, 2019
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
Shipped lot was un released and under quarantine pending investigation closures.
Prolacta Bioscience recalled Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 … - a low-severity action.
Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 … was recalled by Prolacta Bioscience in March 6, 2019. Reason: Shipped lot was un released and under quarantine pending investigation closures.. Check the official notice for the remedy. Verify recall #F-1099-2019 with the FDA Food before acting.
The recall
Prolacta Bioscience issued this low-severity FDA Food recall-Shipped lot was un released and under quarantine pending investigation closures..
- Low
- severity level
- Class III
- classification
- March 6, 2019
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-1099-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-1099-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on January 29, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Prolacta Bioscience is listed as the recalling firm, operating out of Duarte, CA. Federal records list the affected scope as 16 bottles (1 case with 4 individual bottles per carton).
The documented reason for this recall is: Shipped lot was un released and under quarantine pending investigation closures. Distribution data in the federal record shows the product reached: One customer in NC. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
16 bottles (1 case with 4 individual bottles per carton)
Related Recalls
6
2 from same agency
Product description
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
Reason for recall
Shipped lot was un released and under quarantine pending investigation closures.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | F-1099-2019 |
| Date reported | March 6, 2019 |
| Date initiated | January 29, 2019 |
| Recalling firm | Prolacta Bioscience |
| Firm location | Duarte, CA |
| Affected scope | 16 bottles (1 case with 4 individual bottles per carton) |
| Distribution | One customer in NC |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-1099-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Prolacta Bioscience. Units affected: 16 bottles (1 case with 4 individual bottles per carton).
Why was this product recalled? ▼
Shipped lot was un released and under quarantine pending investigation closures.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 6, 2019. Severity: Low. Recall number: F-1099-2019.
Where was the recalled product distributed? ▼
Distribution: One customer in NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-1099-2019) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Cosmetics & Personal Care · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 1387 other recalls in this category.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported March 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.