💊

Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

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

Class I - Dangerous

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

Jan 29, 2025 Prescription Drugs Nationwide View Details →

Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.

The Harvard Drug Group LLC

Class I - Dangerous

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Jan 21, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jan 29, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jan 29, 2025 Prescription Drugs Nationwide View Details →

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

AvKARE

Class I - Dangerous

Out of Specification for Dissolution

Jan 21, 2025 Prescription Drugs Nationwide View Details →

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

RemedyRepack

Class I - Dangerous

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

Jan 24, 2025 Prescription Drugs View Details →

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

PAI Holdings, LLC.

Class I - Dangerous

Superpotent; sodium benzoate preservative

Jan 7, 2025 Prescription Drugs View Details →

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

Class I - Dangerous

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

Jan 22, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jan 22, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Failed Dissolution Specifications.

Jan 30, 2025 Prescription Drugs Nationwide View Details →

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Jan 10, 2025 Prescription Drugs Nationwide View Details →

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

ENDO USA

Class I - Dangerous

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

Dec 20, 2024 Other Drugs Nationwide View Details →

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

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jan 24, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jan 24, 2025 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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.

Jan 23, 2025 Prescription Drugs View Details →

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2

The W.S. Badger Company

Class I - Dangerous

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

Jan 17, 2025 Other Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

The Harvard Drug Group LLC

Class I - Dangerous

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Jan 13, 2025 Prescription Drugs Nationwide View Details →

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

Astellas Pharma US

Class I - Dangerous

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Dec 23, 2024 Prescription Drugs Nationwide View Details →

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

McKesson

Class I - Dangerous

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Jan 17, 2025 Prescription Drugs Nationwide View Details →

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.

Astellas Pharma US

Class I - Dangerous

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Dec 23, 2024 Prescription Drugs Nationwide View Details →