Class IITerminated · reported 2017-02-08

Nepro Vanilla High Protein , 8oz metal can

Abbott Nutrition recalled this product and the FDA reported the enforcement action on 8 February 2017 as Class II. The recall was initiated by the firm. The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.

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: Nepro Vanilla High Protein , 8oz metal can
Reason for recall: The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.
Recalling firm: Abbott Nutrition
Firm location: Altavista, Virginia, United States
Classification: Class II
Status: Terminated
Recall number: F-1421-2017
Quantity: 37,584 units
Distribution: The product was distributed in the US as well as the following foreign countries: Guam and Puerto Rico, Israel, Kuwait, Trinidad and Tobago
Initiated: 9 May 2016
Reported by FDA: 8 February 2017
Terminated: 31 January 2017
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Lot Number 57648RA00 Expiration Date 1Jan1017

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 is one of 6 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. All 6 of them are listed on this page.
The recall ran for 9 months, from 9 May 2016 to termination on 31 January 2017. 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 9 months 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.

Every product in this recall

The FDA opened 6 enforcement records for this one recall, one per product code. This page carries all of them; the 5 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 5 records of FDA event 76167
Reported	Product	Firm	Reason	Class
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 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

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 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
2014-02-26	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 INGREDIENTSUSE BY**ABBOTT LABORATORIES"	Abbott Nutrition	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	Class II

All 9 records for Abbott Nutrition

All 2017 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.