Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON…
Abbott Nutrition recalled this product and the FDA reported the enforcement action on 26 February 2014 as Class II. The recall was initiated by the firm. Abbott 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 leak
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 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"
- Reason for recall
- Abbott 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 leak
- Recalling firm
- Abbott Nutrition
- Firm location
- Columbus, Ohio, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1540-2014
- Quantity
- Lot # L31056Z200-249cs/3 ctns/50/0.9 oz packets; Lot L27385Z200-328 cs/3 ctns/50/0.9 oz packets & Lot L30698Z200-349 cs/3 ctns/50/0.9 oz packets.
- Distribution
- All product in these lots were shipped to Canada.
- Initiated
- 11 October 2013
- Reported by FDA
- 26 February 2014
- Terminated
- 11 April 2014
- Firm notified by
- Letter
- Product codes
- Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1; Lot L27385Z200 List # 54598-934(13) USE BY 2014OC1 & Lot L30698Z200 List # 54598 -934(13) USE BY 2015JA1
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 6 months, from 11 October 2013 to termination on 11 April 2014. 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 5 months after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was about typical for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
Filed under milk and dairy. A product can sit in more than one.
Other milk and dairy recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-09-07 | Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per case | ABBOTT NUTRITION | Packaging defect | Class II |
| 2017-02-08 | Nepro Vanilla , 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2017-02-08 | Oxepa, 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2017-02-08 | Vital High Protein, 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2017-02-08 | Nepro Vanilla High Protein , 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2017-02-08 | Nepro Mixed Berry, 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2017-02-08 | Promote with Fiber Vanilla, 8oz metal can | Abbott Nutrition | The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination. | Class II |
| 2016-04-13 | The 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 Nutrition | Abbott 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 may | Class II |
All 9 records for Abbott Nutrition
All 2014 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 accessRecall 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.