Class IITerminated · reported 2022-09-07

Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per…

ABBOTT NUTRITION recalled this product and the FDA reported the enforcement action on 7 September 2022 as Class II. The recall was initiated by the firm. Packaging defect

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product
Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per case
Reason for recall
Packaging defect
Recalling firm
ABBOTT NUTRITION
Firm location
Columbus, Ohio, United States
Classification
Class II
Status
Terminated
Recall number
F-1705-2022
Quantity
720 bottles
Distribution
Michigan and Ohio
Initiated
16 August 2022
Reported by FDA
7 September 2022
Terminated
29 March 2023
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Batch/Lot No. 41740RH00 Product No. 57512 Best By: 06/01/23

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
  • The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
  • This record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 7 months, from 16 August 2022 to termination on 29 March 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
  • The FDA published the enforcement report 3 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Other records from ABBOTT NUTRITION

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 8 other records name this firm.

ReportedProductFirmReasonClass
2017-02-08Nepro Vanilla , 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2017-02-08Oxepa, 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2017-02-08Vital High Protein, 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2017-02-08Nepro Vanilla High Protein , 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2017-02-08Nepro Mixed Berry, 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2017-02-08Promote with Fiber Vanilla, 8oz metal canAbbott NutritionThe firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.Class II
2016-04-13The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .Abbott NutritionAbbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans mayClass II
2014-02-26Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"Abbott NutritionAbbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leakClass II

All 9 records for Abbott Nutrition

All 2022 recalls · All FDA food recall data

Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.