Pedialyte and Similac Infant Formulas Recalled for Potential Spoilage

Agency Publication Date: November 17, 2022

Summary

Abbott Laboratories has recalled approximately 176,339,088 bottles of Pedialyte and various Similac infant formulas because the bottle seals may not be secure. A compromised seal can lead to product spoilage, making the formula or electrolyte solution unsafe for consumption. This recall involves 2 fl. oz. plastic reclosable bottles sold in multi-packs, cartons, and cases across authorized retailers.

Risk

A compromised seal integrity could lead to the spoilage of the formula or electrolyte solution. If a spoiled product is consumed, it could cause illness, particularly in infants and children who rely on these products for nutrition and hydration.

What You Should Do

This recall affects Pedialyte Unflavored Electrolyte Solution and several Similac brand infant formulas including 360 Total Care, Neosure, Total Comfort, and Special Care, sold in 2 fl. oz. reclosable plastic bottles.
Check the lot number located on the side of the product label and the bottom of the 2 fl. oz. bottle. For multi-packs, also check the bottom of the retail case or carton. See the Affected Products section below for the full list of affected codes.
Immediately stop using any affected bottles. Return the product to the place of purchase for a full refund, throw it away, or contact Abbott Laboratories for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Pedialyte Unflavored Electrolyte Solution (2 fl oz)

Variants: 12-4 packs

Item Code:

59892

Lot Numbers:

34589N201 (Exp 05/01/23)

Product: Pedialyte Unflavored (Export to Canada) (2 fl oz)

Variants: 48 count case

Item Code:

5989213

Lot Numbers:

34589N200 (Exp 04/01/23)

Product: Similac 360 Total Care (2 fl oz)

Variants: 6 count carton, 12 count carton, 48 count case

Item Code:

68133

68136

68708

Lot Numbers:

35609N200 (Exp 12/01/22)

39480N200 (Exp 04/01/23)

39633N200 (Exp 04/01/23)

40624N200 (Exp 04/01/23)

40715N200 (Exp 05/01/23)

40738N200 (Exp 05/01/23)

41001N200 (Exp 05/01/23)

377777N200 (Exp 12/01/22)

41756N200 (Exp 06/01/23)

41793N200 (Exp 06/01/23)

41875N200 (Exp 06/01/23)

40716N200 (Exp 05/01/23)

37778N200 (Exp 12/01/22)

40755N200 (Exp 05/01/23)

4296N200 (Exp 04/01/23)

41754N200 (Exp 06/01/23)

38779N200 (Exp 01/01/23)

38493XK00

41543XK00

420258H00

42564XK00

42566XK00

42567XK00

42568XK00

42572XK00

42573XK00

42962N200

430264R00

43579XK00

43580XK00

43581XK00

440324R00

450394R00

Product: Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit (2 fl oz)

Variants: 6 count kit

Item Code:

68264

Lot Numbers:

39480N200 (Exp 04/01/23)

420395E00

Product: Similac 360 Total Care Sensitive (2 fl oz)

Variants: 6 count carton, 12 count carton, 48 count case

Item Code:

68155

68154

68152

68711

Lot Numbers:

40561N200 (Exp 05/01/23)

41843N200 (Exp 06/01/23)

41882N200 (Exp 06/01/23)

39354N200 (Exp 04/01/23)

41858N200 (Exp 06/01/23)

430294R00

430304R00

430314R00

430328H00

430338H00

430348H00

430358H00

430368H00

440408H00

Product: Similac 360 Total Care Sensitive with Nipples (2 fl oz)

Variants: 4 - 6 count carton

Item Code:

68130

Lot Numbers:

35609N200 (Exp 12/01/22)

380124R00

Product: Similac Neosure (2 fl oz)

Variants: 48 count case

Item Code:

56177

Lot Numbers:

35612N200 (Exp 12/01/22)

Product: Similac Total Comfort (2 fl oz)

Variants: 12 - 4 packs, 48 count case

Item Code:

67132

Lot Numbers:

38793N200 (Exp 12/01/22)

39500N200 (Exp 01/01/23)

41802N200 (Exp 03/01/23)

Product: Similac Special Care (2 fl oz)

Variants: 4 count carton

Item Code:

67446

Lot Numbers:

41861N200 (Exp 06/01/23)

440344R00

Product: Similac Stage 1 (Export Colombia) (2 fl oz)

Variants: 48 count case

Item Code:

6647634

Lot Numbers:

39799N200 (Exp 04/01/23)

Product: Similac Stage 1 (Export Dominican Republic) (2 fl oz)

Variants: 48 count case

Item Code:

6647611

Lot Numbers:

40749N200 (Exp 05/01/23)

Product: Similac Water - Sterilized (Export Canada) (2 fl oz)

Variants: 48 count case

Item Code:

5100013

Lot Numbers:

39398N200 (Exp 10/01/23)

Product Images

Labeling, displays the location of the lot code on the individual unit

Labeling, displays the location of the lot code on the retail 12-count case

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91003

Status: Resolved

Manufacturer: Abbott Laboratories

Sold By: authorized retailers

Manufactured In: United States

Units Affected: 12 products (14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 15,865,104 TOTAL bottles; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL; 14,588,544 bottles TOTAL)

Distributed To: 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, District of Columbia, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Pedialyte Unflavored Electrolyte Solution and several Similac brand infant formulas including 360 Total Care, Neosure, Total Comfort, and Special Care, sold in 2 fl. oz. reclosable plastic bottles.

Check the lot number located on the side of the product label and the bottom of the 2 fl. oz. bottle. For multi-packs, also check the bottom of the retail case or carton. See the Affected Products section below for the full list of affected codes.

Immediately stop using any affected bottles. Return the product to the place of purchase for a full refund, throw it away, or contact Abbott Laboratories for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Affected Products

Product: Pedialyte Unflavored Electrolyte Solution (2 fl oz)

Variants: 12-4 packs

Item Code:

59892

Lot Numbers:

34589N201 (Exp 05/01/23)

Product: Pedialyte Unflavored (Export to Canada) (2 fl oz)

Variants: 48 count case

Item Code:

5989213

Lot Numbers:

34589N200 (Exp 04/01/23)

Product: Similac 360 Total Care (2 fl oz)

Variants: 6 count carton, 12 count carton, 48 count case

Item Code:

68133

68136

68708

Lot Numbers:

35609N200 (Exp 12/01/22)

39480N200 (Exp 04/01/23)

39633N200 (Exp 04/01/23)

40624N200 (Exp 04/01/23)

40715N200 (Exp 05/01/23)

40738N200 (Exp 05/01/23)

41001N200 (Exp 05/01/23)

377777N200 (Exp 12/01/22)

41756N200 (Exp 06/01/23)

41793N200 (Exp 06/01/23)

41875N200 (Exp 06/01/23)

40716N200 (Exp 05/01/23)

37778N200 (Exp 12/01/22)

40755N200 (Exp 05/01/23)

4296N200 (Exp 04/01/23)

41754N200 (Exp 06/01/23)

38779N200 (Exp 01/01/23)

38493XK00

41543XK00

420258H00

42564XK00

42566XK00

42567XK00

42568XK00

42572XK00

42573XK00

42962N200

430264R00

43579XK00

43580XK00

43581XK00

440324R00

450394R00

Product: Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit (2 fl oz)

Variants: 6 count kit

Item Code:

68264

Lot Numbers:

39480N200 (Exp 04/01/23)

420395E00

Product: Similac 360 Total Care Sensitive (2 fl oz)

Variants: 6 count carton, 12 count carton, 48 count case

Item Code:

68155

68154

68152

68711

Lot Numbers:

40561N200 (Exp 05/01/23)

41843N200 (Exp 06/01/23)

41882N200 (Exp 06/01/23)

39354N200 (Exp 04/01/23)

41858N200 (Exp 06/01/23)

430294R00

430304R00

430314R00

430328H00

430338H00

430348H00

430358H00

430368H00

440408H00

Product: Similac 360 Total Care Sensitive with Nipples (2 fl oz)

Variants: 4 - 6 count carton

Item Code:

68130

Lot Numbers:

35609N200 (Exp 12/01/22)

380124R00

Product: Similac Neosure (2 fl oz)

Variants: 48 count case

Item Code:

56177

Lot Numbers:

35612N200 (Exp 12/01/22)

Product: Similac Total Comfort (2 fl oz)

Variants: 12 - 4 packs, 48 count case

Item Code:

67132

Lot Numbers:

38793N200 (Exp 12/01/22)

39500N200 (Exp 01/01/23)

41802N200 (Exp 03/01/23)

Product: Similac Special Care (2 fl oz)

Variants: 4 count carton

Item Code:

67446

Lot Numbers:

41861N200 (Exp 06/01/23)

440344R00

Product: Similac Stage 1 (Export Colombia) (2 fl oz)

Variants: 48 count case

Item Code:

6647634

Lot Numbers:

39799N200 (Exp 04/01/23)

Product: Similac Stage 1 (Export Dominican Republic) (2 fl oz)

Variants: 48 count case

Item Code:

6647611

Lot Numbers:

40749N200 (Exp 05/01/23)

Product: Similac Water - Sterilized (Export Canada) (2 fl oz)

Variants: 48 count case

Item Code:

5100013

Lot Numbers:

39398N200 (Exp 10/01/23)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91003

Status: Resolved

Manufacturer: Abbott Laboratories

Sold By: authorized retailers

Manufactured In: United States