Drug Recalls

2,051 drug recalls from federal enforcement feeds.

Showing 1,351–1,400 of 2,051

• Drug Recall · December 20, 2024

  ENDO USA, Inc.

  Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

  Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

  Class I

• Drug Recall · December 19, 2024

  Hikma Injectables USA Inc

  ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office

  Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

  Class II

• Drug Recall · December 19, 2024

  West-Ward Columbus Inc

  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

  Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

  Class III

• Drug Recall · December 19, 2024

  Hikma Injectables USA Inc

  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

  Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

  Class II

• Drug Recall · December 18, 2024

  AvKARE

  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.

  LABELING: LABEL MIX-UP

  Class III

• Drug Recall · December 18, 2024

  AvKARE

  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

  LABELING: LABEL MIX-UP

  Class III

• Drug Recall · December 18, 2024

  Granules Pharmaceuticals Inc.

  Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

  Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

  Class II

• Drug Recall · December 18, 2024

  Eugia US LLC

  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 Acet

  CGMP Deviations

  Class II

• Drug Recall · December 18, 2024

  Alcon Research LLC

  Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

  Non-Sterility

  Class I

• Drug Recall · December 17, 2024

  Amerisource Health Services LLC

  glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60

  Failed Dissolution Specifications:

  Class II

• Drug Recall · December 16, 2024

  FDC Limited

  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

  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

  Class II

• Drug Recall · December 16, 2024

  SHOPPERS- PLAZA

  FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

  Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

  Class I

• Drug Recall · December 16, 2024

  SOMERSET THERAPEUTICS LLC

  Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

  Failed Impurities/Degradation Specifications

  Class III

• Drug Recall · December 13, 2024

  Amerisource Health Services LLC

  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 60687-42

  Presence of Foreign Tablets/Capsules

  Class II

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  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.

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  Ascend Laboratories, LLC

  Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

  CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

  Class II

• Drug Recall · December 12, 2024

  Ascend Laboratories, LLC

  Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

  CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

  Class II

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  GNMart LLC

  FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

  Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

  Class I

• Drug Recall · December 12, 2024

  Buy-Herbal

  Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.

  Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

  Class I

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 12, 2024

  Akron Pharma, Inc.

  Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

  Class III

• Drug Recall · December 11, 2024

  Glenmark Pharmaceuticals Inc., USA

  chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

  CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

  Class II

• Drug Recall · December 11, 2024

  Glenmark Pharmaceuticals Inc., USA

  chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

  CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

  Class II

• Drug Recall · December 10, 2024

  VIONA PHARMACEUTICALS INC

  Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless p

  Crystallization

  Class II

• Drug Recall · December 10, 2024

  Regenerative Processing Plant, LLC

  PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82

  Lack of Sterility Assurance

  Class II

• Drug Recall · December 10, 2024

  VIONA PHARMACEUTICALS INC

  Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless

  Crystallization

  Class II

• Drug Recall · December 10, 2024

  Regenerative Processing Plant, LLC

  LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-0

  Lack of Sterility Assurance

  Class II

• Drug Recall · December 6, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceu

  CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

  Class II

• Drug Recall · December 6, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmace

  CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

  Class II

• Drug Recall · December 6, 2024

  Amerisource Health Services LLC

  Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

  Class II

• Drug Recall · December 6, 2024

  Amerisource Health Services LLC

  Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

  Class II

• Drug Recall · December 6, 2024

  Amerisource Health Services LLC

  Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

  Class II

• Drug Recall · December 6, 2024

  Aurobindo Pharma USA Inc

  Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

  CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

  Class II

• Drug Recall · December 6, 2024

  Amerisource Health Services LLC

  Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

  Class II

• Drug Recall · December 5, 2024

  FDC Limited

  Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jer

  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.

  Class II

• Drug Recall · December 4, 2024

  AvKARE

  Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

  Failed Dissolution Specifications

  Class II

• Drug Recall · December 4, 2024

  PD-Rx Pharmaceuticals, Inc.

  DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

  CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

  Class II

• Drug Recall · December 2, 2024

  RemedyRepack Inc.

  Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allenda

  CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

  Class II

• Drug Recall · November 27, 2024

  AvKARE

  Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30

  CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

  Class II

• Drug Recall · November 27, 2024

  AvKARE

  Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

  CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

  Class II

• Drug Recall · November 27, 2024

  AvKARE

  Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

  CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

  Class II

• Drug Recall · November 26, 2024

  Curium US, LLC

  Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tet

  Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

  Class II

• Drug Recall · November 25, 2024

  Macleods Pharmaceuticals Ltd

  Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured

  Failed Impurities/Degradation Specifications

  Class II

• Drug Recall · November 22, 2024

  Provepharm Inc.

  Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

  Discoloration

  Class II

• Drug Recall · November 22, 2024

  Apothecus Pharmaceutical Corp.

  VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

  CGMP deviations: out of specifications for assay

  Class II

• Drug Recall · November 22, 2024

  Jubilant Draximage Inc., dba Jubilant Radiopharma

  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, Kirklan

  Failed Stability Specifications

  Class II