US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

0.9% Buffered Lidocaine HCl

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1248-2022
Class II · Moderate risk Terminated

0.125% Bupivacaine HCl Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1247-2022
Class II · Moderate risk Terminated

Atropine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1246-2022
Class II · Moderate risk Terminated

Amino Acid Injection 50 g/1000 mL

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1245-2022
Class II · Moderate risk Terminated

Alcohol Swabsticks

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 67777-300-01 D-1327-2022
Class II · Moderate risk Terminated

Sterile Alcohol Prep Pads

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 67777-121-16 D-1326-2022
Class II · Moderate risk Terminated

Racepinephrine Inhalation Solution

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0487-5901-99 D-1325-2022
Class II · Moderate risk Terminated

Dakin's Solution

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0436-0672-16 D-1323-2022
Class II · Moderate risk Terminated

A&D Original Ointment

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 11523-0096-3 D-1322-2022
Class II · Moderate risk Terminated

Pataday

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-8150-01 D-1321-2022
Class II · Moderate risk Terminated

GenTeal Tears

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-0518-01 D-1320-2022
Class II · Moderate risk Terminated

Miralax

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 11523-7234-4 D-1319-2022
Class II · Moderate risk Terminated

Debrox

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 63029-321-01 D-1318-2022
Class II · Moderate risk Terminated

Systane Zaditor

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-4011-05 D-1317-2022
Class II · Moderate risk Terminated

Systane Balance

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-1433-02 D-1316-2022
Class II · Moderate risk Terminated

Eye-stream

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-0530-04 D-1315-2022
Class II · Moderate risk Terminated

Systane

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-0429-15 D-1314-2022
Class II · Moderate risk Terminated

Naphcon A eye drops

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0065-0085-15 D-1313-2022
Class II · Moderate risk Terminated

Bisacodyl Suppositories

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 57896-443-01 D-1312-2022
Class II · Moderate risk Terminated

Triple Antibiotic Ointment

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0498-0750-36 D-1311-2022
Class II · Moderate risk Terminated

Telmisartan and Hydrochlorothiazide Tablets USP

Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Glenmark Pharmaceuticals Inc., USA NDC 68462-841-13 D-1306-2022
Class II · Moderate risk Terminated

Telmisartan and Hydrochlorothiazide Tablets USP

Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Glenmark Pharmaceuticals Inc., USA NDC 68462-842-13 D-1305-2022
Class II · Moderate risk Terminated

Testosterone Gel 1%

Reason Superpotent Drug: Out of specification assay result was obtained during stability testing.

Teva Pharmaceuticals USA Inc NDC 0591-3216-17 D-1289-2022
Class II · Moderate risk Terminated

Desmopressin Acetate Tablets

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 16714-884-01 D-1171-2022