Drug Recalls

1,842 drug recalls from federal enforcement feeds.

Showing 1,151–1,200 of 1,842

• 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

  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 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 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 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, 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

  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.

  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

  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

  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

  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

  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

  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 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

  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 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

  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%, 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

  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 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 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

  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 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

  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

  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 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

  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

• 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

  Generitech Corporation

  10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in US

  CGMP Deviations: Inconsistency in the water systems.

  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

  Dr. Reddy's Laboratories, Inc.

  Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

  Failed Impurities/Degradation Specifications

  Class III

• Drug Recall · November 19, 2024

  Mylan Institutional, Inc.

  Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

  Subpotent and Superpotent Drug

  Class II

• Drug Recall · November 19, 2024

  Mylan Institutional, Inc.

  Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265

  Subpotent and Superpotent Drug

  Class II

• Drug Recall · November 19, 2024

  Mylan Institutional, Inc.

  Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265

  Subpotent and Superpotent Drug

  Class II

• Drug Recall · November 19, 2024

  Mylan Institutional, Inc.

  Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265

  Subpotent and Superpotent Drug

  Class II

• Drug Recall · November 19, 2024

  Mylan Institutional, Inc.

  Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265

  Subpotent and Superpotent Drug

  Class II

• Drug Recall · November 19, 2024

  Rising Pharma Holding, Inc.

  Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswic

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

  Class II

• Drug Recall · November 19, 2024

  Rising Pharma Holding, Inc.

  Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Hold

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

  Class II