Pedialyte Unflavored 2 fl oz bottles recalled due to seal integrity defect
Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (compromised seal on oral rehydration solution used by vulnerable populations) where no injury has been reported, meeting the High (3) severity criterion per the FDA rubric.
Plain-English summary
Abbott Laboratories is recalling Pedialyte Unflavored in 2 fl oz plastic reclosable bottles (48 count cases) due to compromised seal integrity. The affected batch is Batch No. 34589N200 with a best-by date of 04/01/23. This defect could allow the product to spoil.
Approximately 14,588,544 bottles were distributed to the United States (all states and Washington DC), Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia.
Consumers who have purchased this product should discontinue use. For questions, contact Abbott Laboratories.
The recalled product
- Product
- Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
- Manufacturer
- Abbott Laboratories
- Category
- Food — Beverages
- Hazard
- Affected units
- 14,588,544
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)
- Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23
Distribution
Part of a larger recall action
This product is one of 12 recalled by Abbott Laboratories under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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