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FDA Recalls

Ridley Block Operations Voluntarily Recalls Ultralyx® 12% Protein Sheep

Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protein Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in


Sundial Herbal Products is Recalling Products Attached Because these Products were Misbranded. The Products are Currently Unapproved Drugs, Recall is Required by the Order

To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mi


Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer


Allergy Alert: KIND Issues Voluntary Recall Due to Undeclared Sesame Seeds in Oats & Honey

KIND Healthy Snacks (KIND) is voluntarily recalling a limited number of Oats & Honey Granola with Toasted Coconut pouches due to the presence of sesame seeds, which is not listed as an ingredient in the product. The label does list “sesame seeds” under the “May Contain” statement.


Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b


ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).


CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the


Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail


The J. M. Smucker Company Issues Voluntary Recall of One Lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula Canned Cat Food

The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride.