US Drug Recall Register

FDA Drug Recalls

220 recalls · Class I, newest first

Class I · High risk Ongoing

Atropine Sulfate Injection

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-4911-11 D-0235-2024
Class I · High risk Ongoing

8.4 % Sodium Bicarbonate Injection

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-6637-24 D-0234-2024
Class I · High risk Ongoing

4.2% Sodium Bicarbonate Injection

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-5534-24 D-0233-2024
Class I · High risk Ongoing

Magnum XXL 9800

Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Meta Herbal D-0206-2024
Class I · High risk Ongoing

SANDIMMUNE Oral Solution

Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Novartis Pharmaceuticals Corporation NDC 0078-0110-22 D-0144-2024
Class I · High risk Ongoing

Up&Up brand dry eye relief

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-800-30 D-0311-2024
Class I · High risk Ongoing

Lubricant Eye Drops

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4811-3 D-0309-2024
Class I · High risk Ongoing

Multi-action Relief Drops

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-2254-3 D-0308-2024
Class I · High risk Ongoing

Lubricant Gel Drops

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4540-3 D-0307-2024
Class I · High risk Ongoing

Lubricant Gel Drops

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4540-5 D-0306-2024
Class I · High risk Ongoing

Lubricant Eye Drops

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4811-5 D-0304-2024
Class I · High risk Ongoing

Leader brand Dry Eye Relief

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0089-1 D-0299-2024
Class I · High risk Ongoing

CVS Health brand

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-704-15 D-0298-2024
Class I · High risk Ongoing

Leader brand Dry Eye Relief

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0088-1 D-0295-2024