FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Aug 10, 2023

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B…

Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Imprimis NJOF, LLC D-1094-2023

Class III · Low risk Terminated Aug 7, 2023

PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Advanced Accelerator Applications USA, Inc. NDC 69488-010-61 D-1085-2023

Class III · Low risk Terminated Aug 2, 2023

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC…

Reason Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

B. Braun Medical Inc. NDC 0264-5802-00 D-1083-2023

Class III · Low risk Terminated Jul 18, 2023

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd…

Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Ascend Laboratories, LLC NDC 67877-749-57 D-1145-2023

Class III · Low risk Terminated Jul 18, 2023

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No…

Reason Out of Specification result observed in content uniformity testing

Sun Pharmaceutical Industries INC NDC 47335-063-86 D-1082-2023

Class III · Low risk Terminated Jul 5, 2023

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…

Reason Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Sun Pharmaceutical Industries INC NDC 62756-232-55 D-0924-2023

Class III · Low risk Terminated Jun 27, 2023

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore…

Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-721-03 D-0899-2023

Class III · Low risk Terminated Jun 12, 2023

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Amring Pharmaceuticals Inc NDC 69918-301-30 D-0871-2023

Class III · Low risk Terminated Jun 6, 2023

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

Reason Labeling: Label Mix-up

HF Acquisition Co LLC NDC 51662-1487-3 D-0870-2023

Class III · Low risk Terminated May 22, 2023

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4…

Reason Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

New England Life Care, Inc. dba Advanced Compounding Solutions NDC 71546-451-25 D-0778-2023

Class III · Low risk Terminated May 18, 2023

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ…

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 13107-014-01 D-0877-2023

Class III · Low risk Terminated May 8, 2023

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only…

Reason Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary…

Amneal Pharmaceuticals of New York, LLC NDC 70121-1574-01 D-0756-2023

Class III · Low risk Terminated Apr 27, 2023

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by…

Reason Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc NDC 51862-638-28 D-0770-2023

Class III · Low risk Terminated Apr 27, 2023

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by…

Reason Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc NDC 51862-637-28 D-0769-2023

Class III · Low risk Terminated Apr 27, 2023

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by…

Reason Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc NDC 51862-636-28 D-0768-2023

Class III · Low risk Terminated Apr 27, 2023

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by…

Reason Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc NDC 51862-635-28 D-0767-2023

Class III · Low risk Terminated Apr 27, 2023

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by…

Reason Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc NDC 51862-634-28 D-0766-2023

Class III · Low risk Terminated Apr 24, 2023

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by…

Reason Product mixup: one foreign tablet found in product.

The Harvard Drug Group NDC 0904-6823-61 D-0570-2023

Class III · Low risk Terminated Apr 13, 2023

Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0547-2023

Class III · Low risk Terminated Apr 13, 2023

Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0546-2023

Class III · Low risk Terminated Apr 13, 2023

Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0545-2023

Class III · Low risk Terminated Apr 13, 2023

Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0544-2023

Class III · Low risk Terminated Apr 10, 2023

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095…

Reason Subpotent Drug: Out of specification results for low potency was obtained.

SCA Pharmaceuticals NDC 70004-085-44 D-0555-2023

Class III · Low risk Terminated Mar 29, 2023

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10…

Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity…

Sun Pharmaceutical Industries INC NDC 47335-615-40 D-0529-2023

Class III · Low risk Terminated Mar 29, 2023

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use…

Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.

Accord Healthcare, Inc. NDC 16729-533-08 D-0528-2023