Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk

Calcium Gluconate 10% for Injection

Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1213-2014
Class I · High risk

Dream Body Slimming Capsule

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.

Terminated Chemical / undeclared Slim Beauty USA D-1222-2014
Class I · High risk

Magic Slim capsules

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Terminated Chemical / undeclared Slim Beauty USA D-1221-2014
Class I · High risk

Dr. Ming's Chinese Capsule

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Terminated Chemical / undeclared Slim Beauty USA D-1220-2014
Class I · High risk

Hyperlyte CR

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-1943-20 D-1275-2014
Class I · High risk

ProcalAmine

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-1915-07 D-1274-2014
Class I · High risk

TrophAmine

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-9341-55 D-1273-2014
Class I · High risk

15% Amino Acids Injection PBP Glass

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-3200-55 D-1272-2014
Class I · High risk

6.9% FreAmine HBC

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-9350-55 D-1271-2014
Class I · High risk

0.9 % Sodium Chloride Injection USP

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-4000-55 D-1270-2014
Class I · High risk

0.9% Sodium Chloride Injection

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0049-31 D-1163-2014
Class I · High risk

5% Dextrose Injection

Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0017-38 D-1162-2014
Class I · High risk

vitaliKOR Ready When You Are

Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules

Terminated Chemical / undeclared Vitality Research Labs LLC D-1364-2014
Class I · High risk

RezzRX capsules

Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Terminated Chemical / undeclared Fossil Fuel Products, LLC D-1248-2014

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