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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 1381–1400 of 18,048 recalls

Class IIICompleted

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Appco Pharma LLC

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

January 16, 2025 · DrugView details →

Class IITerminated

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 dba Major Pharmaceuticals and Rugby Laboratories

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

January 13, 2025 · DrugView details →

Class IIOngoing

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, Inc

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

January 10, 2025 · DrugView details →

Class IIOngoing

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

Johnson, S C and Son, Inc

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

January 8, 2025 · DrugView details →

Class IIITerminated

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. dba Pharmaceutical Associates Inc

Superpotent; sodium benzoate preservative

January 7, 2025 · DrugView details →

Class IIOngoing

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 60687-423-11

Amerisource Health Services LLC

Presence of Foreign Tablets/Capsules

January 7, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Rising Pharma Holding, Inc.

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

December 30, 2024 · DrugView details →

Class IIOngoing

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Rising Pharma Holding, Inc.

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

December 30, 2024 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

Granules Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

December 30, 2024 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm 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.

December 30, 2024 · DrugView details →

Class IIOngoing

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

Eugia US LLC

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

December 27, 2024 · DrugView details →

Class IIOngoing

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

First Aid Beauty Ltd

CGMP Deviations; product intended for quarantine was inadvertently distributed

December 23, 2024 · DrugView 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 Inc.

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

December 23, 2024 · DrugView details →

Class IITerminated

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

Viatris Inc

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

December 23, 2024 · DrugView details →

Class IITerminated

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93

Viatris Inc

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

December 23, 2024 · DrugView 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 Inc.

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

December 23, 2024 · DrugView details →

Class IITerminated

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

December 20, 2024 · DrugView 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, Inc.

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

December 20, 2024 · DrugView details →

Class IIIOngoing

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

West-Ward Columbus Inc

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

December 19, 2024 · DrugView details →

Class IITerminated

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

Hikma Injectables USA Inc

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

December 19, 2024 · DrugView details →

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