US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

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
Class III · Low risk Ongoing

Tropicamide 1%

Reason Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

Fagron Compounding Services NDC 71266-8240-01 D-0125-2024
Class I · High risk Ongoing

Dr. Ergin's SugarMD

Reason MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

Sugarmds LLC D-0138-2024
Class II · Moderate risk Ongoing

Naproxen Tablets

Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Glenmark Pharmaceuticals Inc., USA NDC 68462-188-01 D-0124-2024
Class II · Moderate risk Ongoing

Indomethacin 25mg Capsules

Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Glenmark Pharmaceuticals Inc., USA NDC 68462-406-01 D-0123-2024
Class II · Moderate risk Ongoing

Paroxetine Hydrochloride Tablets USP

Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp. D-0122-2024
Class II · Moderate risk Ongoing

Paroxetine Hydrochloride Tablets USP

Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp. D-0121-2024