Use caution Food recall · FDA · Published October 13, 2022

Similac 360 Total Care Recall: Spoilage Risk Due to Seal Issues

Abbott Laboratories recalls Similac 360 Total Care 2 fl oz bottles due to compromised seals that may cause spoilage. Check batch numbers and best-by dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #F-0156-2023Food Similac ›

Use caution until it’s fixed

Compromised seal integrity which could lead to spoilage

Take action

Contact the company

Recalling firmAbbott Laboratories2900 Easton Square Pl · Columbus, OH 43219-6225

✎ GovInfoNow plain-language explainer

Abbott Laboratories is recalling Similac 360 Total Care 2 fl oz recloseable plastic bottles because the seal integrity may be compromised, which could lead to spoilage. The recall affects specific lots distributed across the U.S., Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia. Consumers should check their product's batch number against the list provided in the record. Read more at govinfonow.com/recall/12225-similac-360-total-care-recall-spoilage-risk-due-to-seal.

Source Summary by GovInfoNow · govinfonow.com/recall/12225-similac-360-total-care-recall-spoilage-risk-due-to-seal · Updated October 10, 2026 · FDA enforcement record: FDA #F-0156-2023

Cite this page

“Similac 360 Total Care Recall: Spoilage Risk Due to Seal Issues.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/12225-similac-360-total-care-recall-spoilage-risk-due-to-seal. Based on FDA recall #F-0156-2023 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0156-2023%22&limit=1).

The FDA announced on Oct. 13, 2022, that Abbott Laboratories is recalling Similac 360 Total Care formula due to compromised seal integrity that could lead to spoilage. The Food and Drug Administration issued the recall for approximately 14.6 million bottles distributed nationwide.

How to tell if you have it

Brand: Similac
Product: Similac 360 Total Care Formula
Packaging: 2 fl oz reclose able plastic bottle in 6 count carton, 12 count carton, or 48 count case
Batch Nos.: 35609N200, 39480N200, 39633N200, 40624N200, 40715N200, 40738N200, 41001N200, 377777N200, 41756N200, 41793N200, 41875N200, 40716N200, 37778N200, 40755N200, 4296N200, 41754N200, 38779N200
Case Nos.: 38493XK00, 39480N200, 39633N200, 40624N200, 40715N200, 41001N200, 41543XK00, 41756N200, 41793N200, 41875N200, 420258H00, 42564XK00, 42566XK00, 42567XK00, 42568XK00, 42572XK00, 42573XK00, 42962N200, 430264R00, 43579XK00, 43580XK00, 43581XK00, 440324R00, 450394R00
Product Nos.: 68133, 68136, 68708
Best By dates: 12/01/22, 02/01/23, 03/01/23, 04/01/23, 05/01/23, 06/01/23, 07/01/23
Distribution: Domestic (all U.S. states and DC), Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia

The hazard

The recalled formula has compromised seal integrity which could lead to spoilage, according to the FDA.

Context

GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Recent Abbott recalls include a Nov. 13, 2025, correction for Alinity ci-series System Control Module performance issues and a Sept. 18, 2025, software issue affecting hq Analyzer results. Other recent recalls of similar products include a June 3, 2026, recall of donor human milk due to contamination and a May 1, 2026, recall of a2 Platinum Premium Infant Formula for possible cereulide toxin contamination.

How to tell if you have this one

Look for Similac 360 Total Care 2 fl oz recloseable plastic bottles packaged in 6 count cartons, 12 count cartons, or 48 count cases. Check the batch numbers (e.g., 35609N200, 39480N200) and best-by dates (ranging from 12/01/22 to 07/01/23) against the record. Product numbers include 68133, 68136, 68708.

Brand
Similac
Category
Food

FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming Foreign: Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia

Recall number	Product, codes & lots	Quantity
F-0154-2023	Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case; Batch No. 34589N201 Case No. 34589N201 Product No. 59892 Best By 05/01/23	14,588,544 bottles TOTAL
F-0155-2023	Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case; Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23	14,588,544 bottles TOTAL
F-0156-2023	Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case; Batch No. 35609N200, 39480N200, 39633N200, 40624N200, 40715N200, 40738N200, 41001N200, 377777N200, 41756N200, 41793N200, 41875N200, 40716N200, 37778N200, 40755N200, 4296N200, 41754N200, 40755N200, 38779N200, 40755N200 Case No. 38493XK00, 39480N200, 39633N200, 40624N200, 40715N200, 41001N200, 41543XK00, 41756N200, 41793N200, 41875N200, 420258H00, 42564XK00, 42566XK00, 42567XK00, 42568XK00, 42572XK00, 42573XK00, 42962N200, 430264R00, 43579XK00, 43580XK00, 43581XK00, 440324R00, 450394R00 Product No. 68133, 68136, 68708, 68133 Best By 12/01/22, 02/01/23, 03/01/23, 04/01/23, 05/01/23, 06/01/23, 07/01/23	14,588,544 bottles TOTAL
F-0157-2023	Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit; Batch No. 39480N200 Case No. 420395E00 Product No. 68264 Best By 04/01/23	14,588,544 bottles TOTAL
F-0158-2023	Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case; Batch No. 40561N200, 41843N200, 41882N200, 39354N200, 41858N200, 41843N200 Case No. 40561N200, 41843N200, 41882N200, 430294R00, 430304R00, 430314R00, 430328H00, 430338H00, 430348H00, 430358H00, 430368H00, 440408H00 Product No. 68155, 68154, 68152, 68711 Best By 04/01/23, 05/01/23, 06/01/23	15,865,104 TOTAL bottles
F-0159-2023	Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton; Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22	14,588,544 bottles TOTAL
F-0160-2023	Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case; Batch No. 35612N200 Case No. 35612N200 Product No. 56177 Best By 12/01/22	14,588,544 bottles TOTAL
F-0161-2023	Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case; Batch No. 38793N200, 39500N200, 41802N200 Case No. 38793N200, 39500N200, 41802N200 Product No. 67132 Best By 12/01/22, 01/01/23, 03/01/23	14,588,544 bottles TOTAL
F-0162-2023	Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton; Batch No. 41861N200 Case No. 440344R00 Product No. 67446 Best By 06/01/23	14,588,544 bottles TOTAL
F-0163-2023	Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case; Batch No. 39799N200 Case No. 39799N200 Product No. 6647634 Best By 04/01/23	14,588,544 bottles TOTAL
F-0164-2023	Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case; Batch No. 40749N200 Case No. 40749N200 Product No. 6647611 Best By 05/01/23	14,588,544 bottles TOTAL
F-0165-2023	Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case; Batch No. 39398N200 Case No. 39398N200 Product No. 5100013 Best By 10/01/23	14,588,544 bottles TOTAL

Based on the official FDA remedy

What to do — step by step

Check Your Product
Verify if your Similac 360 Total Care bottle matches the batch numbers and best-by dates listed in the recall record.
Stop Using Affected Bottles
If your product is part of the recall, stop using it immediately to avoid potential spoilage risks.
Contact Abbott for Remedy
The record does not specify a remedy or return process; contact Abbott Laboratories directly for further instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Oct 13, 2022Firm started the recall
Nov 16, 2022FDA classified it Class II
Nov 23, 2022Published in FDA’s Enforcement Report
Aug 14, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What are the specific batch numbers to check?

Check for batch numbers including 35609N200, 39480N200, 39633N200, 40624N200, 40715N200, 40738N200, 41001N200, 377777N200, 41756N200, 41793N200, 41875N200, 40716N200, 37778N200, 40755N200, 4296N200, 41754N200, and 38779N200.

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Link to this recall

<a href="https://govinfonow.com/recall/12225-similac-360-total-care-recall-spoilage-risk-due-to-seal">Similac 360 Total Care Recall: Spoilage Risk Due to Seal Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #F-0156-2023 (October 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-0156-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.