PlainRecalls
FDA Food Verify with FDA Food → Critical Class I Terminated

MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops - start with one and work up to 5) Organic Proprietary Probiotic Blend 250 mg. Bifidobacterium lactis Bifidobacterium infantis Bifidobacterium bifidum Lactobacillus reuteri Other ingredients: A blend of probiotics in an enzyme enriched substrate, extracted with water from a proprietary blend of three organic grasses.

Reported: December 1, 2021 Initiated: October 28, 2021 #F-0214-2022 Lot# 100420218 = 23,223 Lot# 100520218 = 2,450 units

MARY RUTH ORGANICS issued this FDA Food recall on December 1, 2021. Classified as Critical severity (Class I). Approximately Lot# 100420218 = 23,223 Lot# 100520218 = 2,450 units are affected. The recall was issued because: Internal testing found the presence of Pseudomonas aeruginosa in the product.. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #F-0214-2022) was formally reported on December 1, 2021, with the manufacturer initiating the action on October 28, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. MARY RUTH ORGANICS is listed as the recalling firm, operating out of Los Angeles, CA. Federal records indicate Lot# 100420218 = 23,223 Lot# 100520218 = 2,450 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Internal testing found the presence of Pseudomonas aeruginosa in the product. Distribution data in the federal record shows the product reached: Nationwide distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

Lot# 100420218 = 23,223 Lot# 100520218 = 2,450

Related Recalls

6

0 from same agency

Product Description

MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops - start with one and work up to 5) Organic Proprietary Probiotic Blend 250 mg. Bifidobacterium lactis Bifidobacterium infantis Bifidobacterium bifidum Lactobacillus reuteri Other ingredients: A blend of probiotics in an enzyme enriched substrate, extracted with water from a proprietary blend of three organic grasses.

Reason for Recall

Internal testing found the presence of Pseudomonas aeruginosa in the product.

Details

Recalling Firm
MARY RUTH ORGANICS
Units Affected
Lot# 100420218 = 23,223 Lot# 100520218 = 2,450
Distribution
Nationwide distribution
Location
Los Angeles, CA

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number F-0214-2022
Date reported December 1, 2021
Date initiated October 28, 2021
Recalling firm MARY RUTH ORGANICS
Units affected Lot# 100420218 = 23,223 Lot# 100520218 = 2,450
Distribution Nationwide distribution

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

Lot# 100420218 = 23,223 Lot# 100520218 = 2,450 units affected — million-unit bracket.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops - start with one and work up to 5) Organic Proprietary Probiotic Blend 250 mg. Bifidobacterium lactis Bifidobacterium infantis Bifidobacterium bifidum Lactobacillus reuteri Other ingredients: A blend of probiotics in an enzyme enriched substrate, extracted with water from a proprietary blend of three organic grasses.. Recalled by MARY RUTH ORGANICS. Units affected: Lot# 100420218 = 23,223 Lot# 100520218 = 2,450.
Why was this product recalled?
Internal testing found the presence of Pseudomonas aeruginosa in the product.
Which agency issued this recall?
This recall was issued by the FDA Food on December 1, 2021. Severity: Critical. Recall number: F-0214-2022.
Where was the recalled product distributed?
Distribution: Nationwide distribution.
How do I check if my product is affected by a recall?
Check the product description and recall number (F-0214-2022) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).