US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

Kopi Jantan Tradisional Natural Herbs Coffee

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Brian P. Richardson D-1206-2019
Class III · Low risk Terminated

Telmisartan and Amlodipine Tablets 80 mg/5 mg

Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

AVKARE Inc. NDC 42291-795-30 D-1122-2019
Class II · Moderate risk Terminated

Prostaglandin Tri-Mix 30:30:1 Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1204-2019
Class II · Moderate risk Terminated

Prostaglandin Tri-Mix 20:25:1 Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1203-2019
Class II · Moderate risk Terminated

Prostaglandin Tri-Mix 5:15:0.5 Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1200-2019
Class II · Moderate risk Terminated

Phenol 10% Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1199-2019
Class II · Moderate risk Terminated

Papaverine 30 mg/mL Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1198-2019
Class II · Moderate risk Terminated

Papaverine 30 mg/Phentolamine 0.5 mg/mL

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1197-2019
Class II · Moderate risk Terminated

Hcg 11

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1196-2019
Class II · Moderate risk Terminated

Estrone 5mg/mL Oil Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1195-2019
Class II · Moderate risk Terminated

Heparin 20

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1191-2019
Class II · Moderate risk Terminated

Sodium Bicarbonate 8.4% Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1190-2019
Class II · Moderate risk Terminated

EDTA 1% Sterile Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1189-2019
Class II · Moderate risk Terminated

Lidocaine 1%/Dextrose 12.5%

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1188-2019
Class II · Moderate risk Terminated

Neomycin 40 mg/Polymixin B 200

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1187-2019
Class II · Moderate risk Terminated

Prostaglandin Tri-Mix 60:30:1 Injection

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1186-2019
Class II · Moderate risk Terminated

Interferon 1 Million IU/mL Eye Drops

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1185-2019
Class II · Moderate risk Terminated

Serum Tears 50% Ophthalmic Drops

Reason Lack of sterility assurance.

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy D-1184-2019