PlainRecalls
ModerateClass IITerminated

FDA Food recall · Reported May 4, 2022

Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case

Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store.

Recall #
F-1012-2022
Affected scope
23,928 cartons
Initiated
March 24, 2022
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The Procter & Gamble Company recalled Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per … - a moderate-severity action.

Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per … was recalled by The Procter & Gamble Company in May 4, 2022. Reason: Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online s…. Check the official notice for the remedy. Verify recall #F-1012-2022 with the FDA Food before acting.

The recall

The Procter & Gamble Company issued this moderate-severity FDA Food recall-Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online s….

Moderate
severity level
Class II
classification
May 4, 2022
reported

Sourced from official FDA Food enforcement records. Verify recall #F-1012-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 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.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case

Reason for recall

Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store.

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-1012-2022
Date reported May 4, 2022
Date initiated March 24, 2022
Recalling firm The Procter & Gamble Company
Firm location Cincinnati, OH
Affected scope 23,928 cartons
Distribution Product was sent to a 3rd party for destruction due to not meeting micro specs

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-1012-2022) 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?
Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case. Recalled by The Procter & Gamble Company. Units affected: 23,928 cartons.
Why was this product recalled?
Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store.
Which agency issued this recall?
This recall was issued by the FDA Food on May 4, 2022. Severity: Moderate. Recall number: F-1012-2022.
Where was the recalled product distributed?
Distribution: Product was sent to a 3rd party for destruction due to not meeting micro specs.
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

Food and dietary-supplement notices outside this firm and state, matched by severity timing and product category.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Food, reported May 4, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026