US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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

Marcaine 0.5%

Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Hospira Inc., A Pfizer Company NDC 0409-1610-50 D-0097-2017
Class II · Moderate risk Terminated

Marcaine 0.25%

Reason Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Hospira Inc., A Pfizer Company NDC 0409-1587-50 D-0096-2017
Class III · Low risk Terminated

Premarin

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.

Pfizer Inc. NDC 0046-1104-91 D-1528-2016
Class III · Low risk Terminated

Xanax

Reason Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

Mckesson Packaging Services NDC 63739-669-10 D-1527-2016
Class II · Moderate risk Terminated

Desoximetasone Cream USP

Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Taro Pharmaceuticals, Inc. NDC 51672-1271-7 D-0117-2017
Class II · Moderate risk Terminated

Desoximetasone Cream USP

Reason Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Taro Pharmaceuticals, Inc. NDC 51672-1270-7 D-0116-2017
Class III · Low risk Terminated

mitoXANTRONE Injection USP

Reason Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

Teva Pharmaceuticals USA NDC 0703-4685-01 D-0095-2017
Class II · Moderate risk Terminated

Tri-Mix 18/1/10

Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter

The Apothecary Shoppe LLC D-0004-2017
Class II · Moderate risk Terminated

Methylcobalamin 5000 mcg/mL Injection

Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter

The Apothecary Shoppe LLC D-0002-2017
Class III · Low risk Terminated

Cytotec

Reason Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

Pfizer Inc. NDC 0025-1461-34 D-0424-2017
Class II · Moderate risk Terminated

Ondansetron HCI API

Reason Microbial Contamination of Non-Sterile Product

Cadila Pharmaceuticals Limited D-0164-2017
Class III · Low risk Terminated

Lansoprazole Delayed-Release Capsules

Reason Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

Mckesson Packaging Services NDC 63739-0555-10 D-1550-2016
Class I · High risk Terminated

GlucaGen HypoKit

Reason Defective delivery system: detached needles on the syringe in the kit.

Novo Nordisk Inc NDC 0169-7065-15 D-0217-2017
Class III · Low risk Terminated

Varithena

Reason Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

Biocompatibles U.K., Ltd. NDC 60635-123-01 D-0001-2017
Class II · Moderate risk Terminated

Eye Wash

Reason Lack of assurance of sterility

United Exchange Corporation NDC 0904-6491-20 D-0499-2017
Class II · Moderate risk Terminated

Eye Wash

Reason Lack of assurance of sterility

United Exchange Corporation D-0498-2017
Class II · Moderate risk Terminated

Eye Irrigating Solution

Reason Lack of assurance of sterility

United Exchange Corporation NDC 0536-1083-97 D-0497-2017
Class I · High risk Terminated

Eye Wash

Reason Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

United Exchange Corporation NDC 0904-6491-20 D-0496-2017
Class I · High risk Terminated

Hyoscyamine Sulfate

Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Virtus Pharmaceuticals Opco II L NDC 76439-308-10 D-0214-2017
Class I · High risk Terminated

Hyoscyamine Sulfate

Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Virtus Pharmaceuticals Opco II L NDC 76439-307-10 D-0213-2017
Class I · High risk Terminated

Hyoscyamine Sulfate

Reason Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Virtus Pharmaceuticals Opco II L NDC 76439-309-10 D-0212-2017
Class III · Low risk Terminated

Vyvanse

Reason Presence of Foreign Tablets/Capsules

Shire NDC 59417-103-10 D-0006-2017