Align Digestive De-Stress Capsules Recalled for Failed Microbiological Testing
The Procter & Gamble Company is recalling Align Digestive De-Stress Capsules due to failure to meet microbiological specifications. Approximately 23,928 cartons were intended for destruction but were redirected for online sale instead.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The product failed microbiological testing specifications, but no specific pathogen has been identified in the source material.
Plain-English summary
The Procter & Gamble Company is recalling Align Digestive De-Stress Capsules (21-count bottles in paper cartons) because the product failed to meet microbiological specifications. Approximately 23,928 cartons of the product were affected.
The company had directed the product for destruction due to failure to meet microbiological standards. However, the product was instead redirected for sale through an online store, resulting in this recall.
No illnesses or injuries have been reported in connection with this product. The recall addresses a quality concern related to microbiological testing standards.
Consumers who have purchased affected product with Lot No. 1022171991 (Best By Date 07/31/2022) should discontinue use. Contact Procter & Gamble or the retailer for further instructions.
The recalled product
- Product
- Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case
- Manufacturer
- The Procter & Gamble Company
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 23,928
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 1022171991 Product No. 80347747 Best By Date: 07/31/2022
Distribution
Distribution scope not specified by the agency.
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