Catalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) JKR Pharmacy Ventures, LLC dba Doc Lane’s Veterinary Pharmacy. Lexington, KY. 483 issued 12/19/2025
FEI Number 3033262505
Firm Name JKR Pharmacy Ventures, LLC
Record Type 483
Sta

[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and

Unapproved New Drugs/Misbranded Botox

Kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.

Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP