US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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

Minocycline Hydrochloride Capsules USP

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.

Apace KY LLC NDC 50268-569-11 D-0811-2016
Class II · Moderate risk Terminated

Tobramycin 14 mg/mL Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9996-60 D-0798-2016
Class II · Moderate risk Terminated

Vancomycin 50mg/mL Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9991-54 D-0797-2016
Class II · Moderate risk Terminated

Lidocaine Nebulizer 1% Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9020-61 D-0796-2016
Class II · Moderate risk Terminated

Edetate Disodium 2% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9019-47 D-0795-2016
Class II · Moderate risk Terminated

Acetylcysteine 10% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9018-33 D-0794-2016
Class II · Moderate risk Terminated

Atropine 0.01% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9019-09 D-0793-2016
Class II · Moderate risk Terminated

Vancomycin 25mg/mL Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9003-78 D-0792-2016
Class II · Moderate risk Terminated

Tobramycin 15mg/mL Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9996-35 D-0791-2016
Class II · Moderate risk Terminated

Silver Nitrate 1% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9991-92 D-0790-2016
Class II · Moderate risk Terminated

Rose Bengal 1% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy D-0789-2016
Class II · Moderate risk Terminated

Lidocaine Nebulizer 2% Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9000-99 D-0788-2016
Class II · Moderate risk Terminated

Edetate Disodium 3% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9019-47 D-0787-2016
Class II · Moderate risk Terminated

Cefazolin 50 mg/mL Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9999-69 D-0786-2016
Class III · Low risk Terminated

Scrub-Stat 4

Reason Subpotent drug

Ecolab Inc NDC 47593-265-36 D-0766-2016
Class I · High risk Terminated

Morphine Sulfate 0.5 mg/mL

Reason Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Pharmakon Pharmaceuticals NDC 45183-0322-78 D-0871-2016
Class II · Moderate risk Terminated

Alendronate Sodium Tablets

Reason Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.

Sun Pharma Global Fze NDC 41616-638-68 D-0735-2016
Class III · Low risk Terminated

sulfur8 medicated LIGHT FORMULA

Reason Subpotent Drug: failed at the 3 and 6 month stability time points.

J. Strickland and Co D-0734-2016
Class II · Moderate risk Terminated

TEARS Naturale FREE

Reason Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.

Alcon Research, Ltd. D-0666-2016
Class II · Moderate risk Terminated

Medicated Better Braids

Reason Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.

Keystone Laboratories Inc D-0726-2016
Class II · Moderate risk Terminated

Tudorza Pressair

Reason Defective Delivery System: Some units have actuation counters set to a number other than 60.

AstraZeneca Pharmaceuticals LP D-0781-2016
Class III · Low risk Terminated

Oxygen

Reason CGMP Deviations: Cylinders filled using out of date gauges.

Medical Park Homecare, Inc D-0776-2016
Class II · Moderate risk Terminated

Paricalcitol Capsules

Reason Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.

Teva Pharmaceuticals USA NDC 0093-7656-56 D-0774-2016
Class II · Moderate risk Terminated

0.9% Sodium Chloride Irrigation

Reason PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.

Baxter Healthcare Corp. NDC 0338-0048-03 D-0731-201