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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 821–840 of 1,000 recalls

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 →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

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, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

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, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

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, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

Glenmark Pharmaceuticals Inc., USA

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

January 29, 2025 · DrugView details →

Class IIOngoing

HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10

SKY PACKAGING

Failed Impurities/Degradation Specifications

January 24, 2025 · DrugView details →

Class IIOngoing

HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10

SKY PACKAGING

Failed Impurities/Degradation Specifications

January 24, 2025 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

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 23, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

January 22, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

January 22, 2025 · DrugView details →

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