Pedialyte Unflavored Electrolyte Solution Recalled for Seal Integrity Issues
Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.
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: FDA Class II recall of a pediatric electrolyte solution with compromised seal integrity. No illnesses or injuries reported, capping severity at High per the rubric rule that theoretical hazards without reported harm score at most 3.
Plain-English summary
Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution in 2 fl oz plastic reclosable bottles, sold in 12-4 packs per case, due to compromised seal integrity that could lead to product spoilage.
The affected batch is Batch No. 34589N201 with a Best By date of 05/01/23. A total of 14,588,544 bottles were distributed across all 50 US states and Washington DC, as well as to Canada, Puerto Rico, Bermuda, Curacao, Trinidad and Tobago, Panama, Dominican Republic, and Colombia.
Pedialyte is an oral electrolyte replacement solution used to restore fluids and electrolytes.
The recalled product
- Product
- Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
- Manufacturer
- Abbott Laboratories
- 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. 34589N201 Case No. 34589N201 Product No. 59892 Best By 05/01/23
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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