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Abbott Laboratories
FDA recall F-0158-2023 · Class II · reported 2022-11-23 · Terminated
- Product
- Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
- Reason
- Compromised seal integrity which could lead to spoilage
- Quantity
- 15,865,104 TOTAL bottles
- 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
- Firm location
- OH, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2022-10-13
- Terminated
- 2024-08-14
- Code info
- 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
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.