US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Ongoing

Goal

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1204-2022
Class II · Moderate risk Ongoing

Folic Acid 5mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1202-2022
Class II · Moderate risk Ongoing

Estradiol Cypionate 10mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1201-2022
Class II · Moderate risk Ongoing

Dexpanthenol 250mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1199-2022
Class II · Moderate risk Ongoing

Calcium Chloride Preservative Free

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1198-2022
Class II · Moderate risk Ongoing

Biotin 5mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1197-2022
Class II · Moderate risk Ongoing

BCAAs

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1196-2022
Class II · Moderate risk Ongoing

Ascorbic Acid 500mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1195-2022
Class II · Moderate risk Ongoing

Alpha Lipoic Acid 25mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1192-2022
Class III · Low risk Terminated

Nandrolone Decanoate

Reason Subpotent Drug

Fagron, Inc NDC 0395-8212-43 D-0866-2022
Class III · Low risk Terminated

Nandrolone Decanoate

Reason Subpotent Drug

Fagron, Inc NDC 0395-8212-56 D-0865-2022
Class III · Low risk Terminated

Nandrolone Decanoate

Reason Subpotent Drug

Fagron, Inc NDC 51552-1564-07 D-0864-2022
Class III · Low risk Terminated

Nandrolone Decanoate

Reason Subpotent Drug

Fagron, Inc NDC 51552-1564-05 D-0863-2022
Class III · Low risk Terminated

Nandrolone Decanoate

Reason Subpotent Drug

Fagron, Inc NDC 51552-1564-04 D-0862-2022
Class I · High risk Completed

SyrSpend SF Suspending Base

Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Fagron, Inc NDC 51552-1123-5 D-0856-2022
Class I · High risk Terminated

Sodium Acetate Injection

Reason Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Fresenius Kabi USA, LLC NDC 63323-032-00 D-0750-2022
Class II · Moderate risk Terminated

Alprazolam C-IV 2 mg

Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Direct Rx NDC 72189-0058-60 D-0651-2022
Class II · Moderate risk Terminated

Alprazolam C-IV 1 mg 60-count bottles

Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Direct Rx NDC 61919-836-60 D-0650-2022
Class II · Moderate risk Terminated

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Tennessee Technical Coatings, Corp. NDC 76921-000-01 D-0740-2022
Class I · High risk Terminated

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%

Reason Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.

Tennessee Technical Coatings, Corp. NDC 76921-000-01 D-0739-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Golden State Medical Supply Inc. NDC 60429-504-18 D-0654-2022