US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1450-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1449-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1448-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical Contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1447-2020
Class I · High risk Terminated

NP Thyroid 90

Reason Superpotent Drug.

Acella Pharmaceuticals, LLC NDC 42192-331-01 D-1300-2020
Class I · High risk Terminated

NP Thyroid 60

Reason Superpotent Drug.

Acella Pharmaceuticals, LLC NDC 42192-330-01 D-1299-2020
Class I · High risk Terminated

NP Thyroid 30

Reason Superpotent Drug.

Acella Pharmaceuticals, LLC NDC 42192-329-01 D-1298-2020
Class I · High risk Terminated

LACTATED RINGER'S Injection

Reason Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

ICU Medical Inc NDC 0409-7953-09 D-1270-2020
Class I · High risk Terminated

Ketorolac Tromethamine Injection

Reason Presence of Particulate Matter - found in reserve sample vials at the firm.

Fresenius Kabi USA, LLC NDC 63323-162-00 D-1296-2020
Class I · High risk Terminated

Finasteride Plus 1.25 mg Capsule

Reason Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

MasterPharm LLC D-1269-2020
Class I · High risk Terminated

Tetracycline HCL Capsules

Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Avet Pharmaceuticals, Inc. NDC 23155-017-01 D-1255-2020
Class I · High risk Terminated

Tetracycline HCL Capsules

Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Avet Pharmaceuticals, Inc. NDC 23155-018-01 D-1254-2020
Class I · High risk Terminated

Phytonadione Injectable Emulsion

Reason Defective Container: Recall is due to breaking and shattering of ampules upon opening

Dr. Reddy's Laboratories, Inc. NDC 43598-405-11 D-1094-2020
Class I · High risk Terminated

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary…

Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

Y-O Management LLC, dba Natural Remedy Store D-1080-2020
Class I · High risk Terminated

Phenytoin Oral Suspension USP

Reason Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4069-1 D-0863-2020
Class I · High risk Terminated

Ketorolac Trom

Reason Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

RemedyRepack Inc. NDC 70518-1239-00 D-0867-2020
Class I · High risk Terminated

Lamotrigine Tablets

Reason Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4131-1 D-0833-2020
Class I · High risk Terminated

Ketorolac Tromethamine Injection

Reason Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Hikma Pharmaceuticals USA Inc. NDC 0641-6042-01 D-0864-2020
Class I · High risk Terminated

Panther Platinum 30000 Capsules

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Motto International Corp D-0657-2020
Class I · High risk Terminated

Rhino 7 Platinum 30000 Capsules

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Motto International Corp D-0656-2020
Class I · High risk Terminated

Stallion Platinum 30000 Capsules in blue

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Motto International Corp D-0655-2020
Class I · High risk Terminated

Bull Platinum 30000 Capsules

Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Motto International Corp D-0654-2020