CLASS II Food recall · Reported 23 Nov 2022 · FDA Enforcement Report

Similac 360 Total Care Sensitive recalled by Abbott Laboratories

Abbott Laboratories is recalling Similac 360 Total Care Sensitive with Nipples reclose able Packaged as: 4, distributed in 51 states. The recall was initiated on 13 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22
Quantity recalled14,588,544 bottles TOTAL

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number
F-0159-2023
FDA event ID
91003
Recalling firm
Abbott Laboratories, Columbus, OH
Brand
Similac
Classification
Class II
Status
Terminated
Recall initiated
13 Oct 2022
FDA classified
16 Nov 2022
Reported
23 Nov 2022
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Mold
Product category
Baby Formula

Timeline

13 Oct 2022Recall initiated by company
16 Nov 2022Classified by FDA+34 days
23 Nov 2022Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Compromised seal integrity which could lead to spoilage

Product as listed by the FDA

Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton

Where it was distributed

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

AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland

Questions about this recall

Is Similac 360 Total Care Sensitive with Nipples reclose able Packaged as: 4 recalled?

Yes. Abbott Laboratories recalled Similac 360 Total Care Sensitive with Nipples reclose able Packaged as: 4 on 13 Oct 2022. The recall is Class II and its status is Terminated. Recall number F-0159-2023.

Why was it recalled?

Compromised seal integrity which could lead to spoilage

Which lots are affected?

Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22

Where was it sold?

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

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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