US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated

Teething Drops

Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.

MBi Distributing Inc. dba MBi Nutraceuticals D-0867-2018
Class I · High risk Terminated

Piperacillin and Tazobactam for Injection

Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. NDC 60505-0688-4 D-0840-2018
Class I · High risk Terminated

Piperacillin and Tazobactam for Injection

Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. NDC 60505-0687-4 D-0839-2018
Class II · Moderate risk Terminated

Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57896-709-16 D-0853-2018
Class II · Moderate risk Terminated

Gericare Diocto Liquid

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57896-403-16 D-0852-2018
Class II · Moderate risk Terminated

SDA Senna Syrup

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 66424-562-08 D-0851-2018
Class II · Moderate risk Terminated

Geritrex Senna Syrup

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 54162-007-08 D-0850-2018
Class II · Moderate risk Terminated

Ritussin DM Dextromethorphan Hydrobormide

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0849-2018
Class II · Moderate risk Terminated

GeriCare Senna Syrup

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57696-452-08 D-0848-2018
Class II · Moderate risk Terminated

RPC APAP Elixir

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-129-16 D-0847-2018
Class II · Moderate risk Terminated

RPC Children's Non-Aspirin

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-129-04 D-0845-2018
Class II · Moderate risk Terminated

RPC Senna Syrup

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0844-2018
Class II · Moderate risk Terminated

Preferred Plus Pharmacy Antacid

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0843-2018
Class II · Moderate risk Terminated

Preferred Plus Pharmacy Antacid Extra Strength

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-158-12 D-0842-2018
Class II · Moderate risk Terminated

Hydrocortisone Ointment

Reason Failed Stability Specifications

Perrigo New York NDC 45802-014-02 D-0817-2018
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Noven Pharmaceuticals, Inc. NDC 68968-6637-1 D-0863-2018
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Noven Pharmaceuticals, Inc. NDC 68968-6610-1 D-0862-2018
Class III · Low risk Terminated

Zoma Shampoo

Reason Subpotent

Milbar Laboratories, Inc. D-0833-2018
Class II · Moderate risk Terminated

Naturmetic SPF 50 Sunscreen

Reason GMP Deviations

Milbar Laboratories, Inc. D-0813-2018
Class II · Moderate risk Terminated

B Prox 10 Anti-blemish Wash

Reason Microbial Contamination of Non-sterile Product

Milbar Laboratories, Inc. D-0811-2018