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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 1341–1360 of 18,048 recalls

Class IIOngoing

Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Aspen Biopharma Labs Pvt., Ltd.

CGMP Deviations

February 7, 2025 · DrugView details →

Class IIOngoing

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

Aspen Biopharma Labs Pvt., Ltd.

CGMP Deviations

February 7, 2025 · DrugView details →

Ongoing

Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

Aspen Biopharma Labs Pvt., Ltd.

CGMP Deviations

February 7, 2025 · DrugView details →

Class IICompleted

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30

Padagis US LLC

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

February 6, 2025 · DrugView details →

Class IIOngoing

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Dissolution Specifications

February 6, 2025 · DrugView details →

Class IIOngoing

Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90

AvKARE

Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

February 4, 2025 · DrugView details →

Class IIOngoing

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Direct Rx

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

January 31, 2025 · DrugView details →

Class IICompleted

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Fagron Compounding Services

Lack of Assurance of Sterility

January 31, 2025 · DrugView details →

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.

Alvogen, Inc

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

January 31, 2025 · DrugView details →

Class IIOngoing

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Dissolution Specifications.

January 30, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

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