Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,085 FDA drug recalls in 2013.

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Date	Product	Reason	Class	Firm
Sep 17, 2013	Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013	Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013	Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lup...	Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo...	Class II	Lupin Pharmaceuticals Inc.
Sep 17, 2013	Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syring...	Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefi...	Class II	Amgen, Inc.
Sep 17, 2013	Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013	Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lu...	Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo...	Class II	Lupin Pharmaceuticals Inc.
Sep 16, 2013	Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per b...	Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not ...	Class II	Kremers Urban Pharmaceuticals, Inc.
Sep 16, 2013	Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage ...	Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the ...	Class II	Hospira, Inc.
Sep 16, 2013	Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, pac...	Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.	Class III	Osmotica Pharmaceutical Corp
Sep 16, 2013	1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L...	Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochlor...	Class I	Hospira, Inc.
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bott...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (ND...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intrave...	Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri...	Class II	AmeriSource Bergen
Sep 13, 2013	Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmac...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC ...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles...	Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sea...	Class II	Watson Laboratories Inc
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottle...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bott...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 1...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottl...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 1...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC ...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmace...	CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa...	Class II	Mylan Pharmaceuticals Inc.
Sep 13, 2013	Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intrav...	Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri...	Class II	AmeriSource Bergen
Sep 11, 2013	Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J...	Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril...	Class II	Janssen Pharmaceuticals, Inc.
Sep 11, 2013	Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consume...	Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.	Class III	Physicians Total Care, Inc.
Sep 9, 2013	Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 9, 2013	Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085...	Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin...	Class II	Avella of Deer Valley, Inc.
Sep 9, 2013	Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 9, 2013	Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 8...	Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin...	Class II	Avella of Deer Valley, Inc.
Sep 9, 2013	Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 9, 2013	Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 9, 2013	Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 9, 2013	Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1...	Defective Container: Stability samples of both products were noted to have some white solid produ...	Class III	PACK Pharmaceuticals, LLC
Sep 8, 2013	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118....	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t...	Class III	Hill Dermaceuticals, Inc.
Sep 8, 2013	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118....	Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t...	Class III	Hill Dermaceuticals, Inc.
Sep 6, 2013	Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Comp...	Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ...	Class II	University Compounding Pharmacy
Sep 6, 2013	Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The...	Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent ...	Class II	Apothecary Shoppe
Sep 6, 2013	PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding P...	Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ...	Class II	University Compounding Pharmacy
Sep 6, 2013	Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, ...	Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro...	Class II	Triangle Compounding
Sep 6, 2013	PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Ph...	Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ...	Class II	University Compounding Pharmacy
Sep 6, 2013	Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl...	Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ...	Class I	Altaire Pharmaceuticals, Inc.
Sep 6, 2013	Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL ...	Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro...	Class II	Triangle Compounding
Sep 6, 2013	SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apot...	Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent ...	Class II	Apothecary Shoppe
Sep 6, 2013	Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, Universit...	Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ...	Class II	University Compounding Pharmacy
Sep 6, 2013	Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL ...	Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ...	Class II	University Compounding Pharmacy
Sep 6, 2013	Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berr...	Presence of Foreign Substance: process-related particulates which may be associated with the raw ...	Class II	Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
Sep 5, 2013	0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial,...	Lack of Assurance of Sterility; potential for vial breakage	Class II	Hospira Inc.
Sep 5, 2013	Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL s...	Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility ass...	Class II	Fallon Wellness Pharmacy Llc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.