Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 751–800 of 1,842

Drug Recall · July 22, 2025
Hikma Pharmaceuticals USA Inc.
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II
Drug Recall · July 22, 2025
Taizhou Kangping Medical Science And Technology Co., Ltd.
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu,
Lack of Assurance of Sterility.
Class II
Drug Recall · July 21, 2025
Ascend Laboratories, LLC
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC
Failed Dissolution Specifications: low dissolution results
Class II
Drug Recall · July 21, 2025
Merck & Co. Inc
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpa
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Class II
Drug Recall · July 21, 2025
YANGZHOU YULOU PAPER PRODUCTS CO., LTD
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
cGMP Deviations
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, W
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkl
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirklan
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirk
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkl
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirk
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland,
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirklan
Lack of Processing Controls.
Class II
Drug Recall · July 18, 2025
AEQUITA PHARMACY
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita
Lack of Processing Controls.
Class II
Drug Recall · July 17, 2025
DermaRite Industries, LLC
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I
Drug Recall · July 17, 2025
DermaRite Industries, LLC
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I
Drug Recall · July 17, 2025
DermaRite Industries, LLC
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I
Drug Recall · July 17, 2025
DermaRite Industries, LLC
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I
Drug Recall · July 15, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, I
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II
Drug Recall · July 11, 2025
Nostrum Laboratories, Inc.
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II
Drug Recall · July 10, 2025
A.P. Deauville, LLC
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
CGMP Deviations
Class II
Drug Recall · July 10, 2025
A.P. Deauville, LLC
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
CGMP Deviations
Class II
Drug Recall · July 10, 2025
Pfizer Inc.
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10,
CGMP Deviations; particulates identified during visual inspection
Class II
Drug Recall · July 10, 2025
A.P. Deauville, LLC
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 81519501
CGMP Deviations
Class II
Drug Recall · July 10, 2025
Pfizer Inc.
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , S
CGMP Deviations; particulates identified during visual inspection
Class II
Drug Recall · July 9, 2025
Ascend Laboratories, LLC
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II
Drug Recall · July 9, 2025
Boothwyn Pharmacy LLC
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Subpotent Drug
Class II
Drug Recall · July 9, 2025
Boothwyn Pharmacy LLC
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Subpotent Drug
Class II
Drug Recall · July 9, 2025
Imprimis NJOF, LLC
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07
Sub-Potent Drug: Subpotent assay results during stability testing.
Class III
Drug Recall · July 9, 2025
Boothwyn Pharmacy LLC
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Subpotent Drug
Class III
Drug Recall · July 9, 2025
Imprimis NJOF, LLC
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II
Drug Recall · July 9, 2025
Strides Pharma, Inc.
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Failed Dissolution Specifications.
Class II
Drug Recall · July 9, 2025
Ascend Laboratories, LLC
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II
Drug Recall · July 9, 2025
Boothwyn Pharmacy LLC
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Subpotent Drug
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA,
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case)
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 7, 2025
MEDLINE INDUSTRIES, LP - Northfield
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II
Drug Recall · July 5, 2025
FDC Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jerse
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II
Drug Recall · July 2, 2025
Lupin Pharmaceuticals Inc.
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited,
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II
Drug Recall · July 1, 2025
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los A
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II
Drug Recall · June 30, 2025
Cipla USA, Inc.
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II
Drug Recall · June 30, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · June 30, 2025
Dr. Reddy's Laboratories, Inc.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals He
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II