The Recall Desk
HighFDA (Food)·F-0154-2023·Announced 2022-11-23

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.

What this means for you

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
Category
Drug — Electrolyte Replacement Solution
Hazard
  • seal-compromise
  • spoilage

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

Distributed in 1 state:

  • DC

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