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Data / Product recalls / Abbott Laboratories

Abbott Laboratories: 9 recalls from 2015 to 2023 (FDA)

Abbott Laboratories, Columbus, OH, is named in 9 recalls from 2015 to 2023: all from the FDA. The latest, on November 15, 2023, covers Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.. Hazard: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive. Source: FDA F-0328-2024.

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Country
United States
Location
Columbus, OH
Agencies
U.S. Food and Drug Administration
First recall
March 18, 2015
Latest recall
November 15, 2023

Recalls

Each recall is listed once, with the role this firm has in it. Roles: recalling firm (9).

DateAgencyProductHazardUnitsRemedySold atRoleSource
November 15, 2023FDASimilac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive226,650 packets (4,533 cartons)Voluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov
April 19, 2023FDAZone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard cartonPotential of foreign material (hard plastic) within product646,668 barsVoluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov
November 23, 2022FDAPedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case and 11 more productsCompromised seal integrity which could lead to spoilage14,588,544 bottles TOTAL (first of 12 products)Voluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov
August 31, 2022FDAAbbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L)...Potential leaking/pinholes in bottle179 cases (1,432 bottles)Voluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov
June 29, 2022FDAPedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER... and 1 more productThese products are being recalled due to the potential of leakage from the 1L container.50,502 (2-count cases) (first of 2 products)Voluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov
June 22, 2022FDAPedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g)...The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.789 cases/4734 cartons/28,404 packetsVoluntary recall, Class III, terminatedRecalling firmaccessdata.fda.gov
March 16, 2022FDAAbbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591 and 40 more productsConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced6359 cases (first of 41 products)Voluntary recall, Class I, ongoingRecalling firmaccessdata.fda.gov
October 16, 2019FDAAbbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.2,922 cansFDA Mandated recall, Class II, terminatedRecalling firmaccessdata.fda.gov
March 18, 2015FDASimilac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.The firm received three consumer calls of product with Chinese labeling. After an internal investigation, the firm discovered that product manufactured for export to China was distributed to three states in the US. All labeling is in...51,642/1.45lb containersVoluntary recall, Class II, terminatedRecalling firmaccessdata.fda.gov

By agency

AgencyRecallsLatest
U.S. Food and Drug Administration9November 15, 2023

Categories

Where each agency publishes its recalls

Updated November 15, 2023. Read from U.S. Food and Drug Administration recall data. CC0 1.0 (openFDA). Recalls are as the agencies published them: the CPSC, FDA (food enforcement reports) and NHTSA. A firm is one firm only when its exact name and country match; the CPSC and FDA print no firm ID. Stores are listed only when the agency's sold-at text names them, and an agency often adds that more stores sold the product. Categories are grouped by SpecStream from the words in the agency's title and product text. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.