Showing 1,401–1,420 of 18,047 drug recalls
Drug Recall
Ongoing
Historical record Class III
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01. by Akron Pharma, Inc.
Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Recall initiated
December 12, 2024 Reported by FDA
January 22, 2025 Distribution
Nationwide in the US
View recall →
Drug Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 by Rising Pharma Holding, Inc.
Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Recall initiated
December 30, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10 by Granules Pharmaceuticals Inc.
Reason
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. Recall initiated
December 30, 2024 Reported by FDA
January 15, 2025 Distribution
Distributor in OH.
View recall →
Drug Recall
Ongoing
Historical record Class II
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05. by Jubilant Draximage Inc., dba Jubilant Radiopharma
Reason
Failed Stability Specifications Recall initiated
November 22, 2024 Reported by FDA
January 15, 2025 Distribution
US Nationwide.
View recall →
Drug Recall
Ongoing
Historical record Class II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ by Rising Pharma Holding, Inc.
Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Recall initiated
December 30, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide
View recall →
Drug Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ by Rising Pharma Holding, Inc.
Reason
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Recall initiated
December 30, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 by Granules Pharmaceuticals Inc.
Reason
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. Recall initiated
December 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide within the United States
View recall →
Drug Recall
Ongoing
Historical record Class II
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 by Eugia US LLC
Reason
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. Recall initiated
December 27, 2024 Reported by FDA
January 15, 2025 Distribution
Distributed Nationwide in the USA.
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Drug Recall
Ongoing
Historical record Class II
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India by Eugia US LLC
Reason
CGMP Deviations Recall initiated
December 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide in the US
View recall →
Drug Recall
Ongoing
Historical record Class II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 by Amerisource Health Services LLC
Reason
Presence of Foreign Tablets/Capsules Recall initiated
December 13, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide within the United States
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Drug Recall
Ongoing
Historical record Class III
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 by West-Ward Columbus Inc
Reason
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. Recall initiated
December 19, 2024 Reported by FDA
January 15, 2025 Distribution
US Nationwide.
View recall →
Drug Recall
Ongoing
Historical record Class II
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 by FDC Limited
Reason
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle Recall initiated
December 16, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide
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Drug Recall
Ongoing
Historical record Class I
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters). by ENDO USA, Inc.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Recall initiated
November 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide in the USA
View recall →
Drug Recall
Ongoing
Historical record Class I
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters). by ENDO USA, Inc.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Recall initiated
November 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide in the USA
View recall →
Drug Recall
Ongoing
Historical record Class I
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters). by ENDO USA, Inc.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Recall initiated
November 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide in the USA
View recall →
Drug Recall
Ongoing
Historical record Class I
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters). by ENDO USA, Inc.
Reason
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Recall initiated
November 18, 2024 Reported by FDA
January 15, 2025 Distribution
Nationwide in the USA
View recall →
Drug Recall
Ongoing
Historical record Class I
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia. by Buy-Herbal
Reason
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine Recall initiated
December 12, 2024 Reported by FDA
January 15, 2025 Distribution
U.S Nationwide.
View recall →
Drug Recall
Ongoing
Historical record Class III
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 by AvKARE
Reason
LABELING: LABEL MIX-UP Recall initiated
December 18, 2024 Reported by FDA
January 8, 2025 Distribution
Nationwide within the United States
View recall →
Drug Recall
Ongoing
Historical record Class III
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. by AvKARE
Reason
LABELING: LABEL MIX-UP Recall initiated
December 18, 2024 Reported by FDA
January 8, 2025 Distribution
Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical record Class II
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 by Hikma Injectables USA Inc
Reason
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Recall initiated
December 19, 2024 Reported by FDA
January 8, 2025 Distribution
Nationwide in the USA
View recall →
Data last updated: October 31, 2026 ET
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer .
