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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1081–1100 of 17,683 recalls

Class IIOngoing

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 USA, Onlyyourrx.com.

Generitech Corporation

CGMP Deviations: Inconsistency in the water systems.

November 22, 2024 · DrugView details →

Class IIIOngoing

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.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

November 22, 2024 · DrugView details →

Class IIOngoing

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

Apothecus Pharmaceutical Corp.

CGMP deviations: out of specifications for assay

November 22, 2024 · DrugView details →

Class IIOngoing

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 26505 USA. NDC: 51079-443-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

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 26505 USA. NDC: 42292-040-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

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 USA. NDC: 51079-442-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

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 26505 USA. NDC: 51079-445-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

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 26505 USA. NDC: 42292-039-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20

Mylan Institutional, Inc.

Subpotent and Superpotent Drug

November 19, 2024 · DrugView details →

Class IIOngoing

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 Brunswick, NJ

Rising Pharma Holding, Inc.

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

November 19, 2024 · DrugView details →

Class IIOngoing

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 Holdings, Inc., East Brunswick, NJ

Rising Pharma Holding, Inc.

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

November 19, 2024 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Rising Pharma Holding, Inc.

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

November 19, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

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).

Endo USA, Inc.

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

November 18, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

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).

Endo USA, Inc.

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

November 18, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc

Superpotent Drug and Subpotent Drug: potency failures obtained

November 18, 2024 · DrugView details →

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