Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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Date	Product	Reason	Class	Firm
Oct 6, 2014	PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds...	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not...	Class II	Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014	EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX,...	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not...	Class II	Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014	PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7...	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not...	Class II	Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014	CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative C...	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not...	Class II	Oregon Compounding Centers, Inc. dba Creative C...
Oct 6, 2014	HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass v...	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not...	Class II	Oregon Compounding Centers, Inc. dba Creative C...
Oct 3, 2014	Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-...	Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as...	Class II	Sagent Pharmaceuticals Inc
Oct 3, 2014	CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocain...	Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tes...	Class II	Wisconsin Pharmacal Company
Oct 2, 2014	Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture...	Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ...	Class III	Valeant Pharmaceuticals International
Oct 2, 2014	candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur...	Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ...	Class III	Sandoz, Inc
Oct 2, 2014	VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co...	Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.	Class II	West-Ward Pharmaceutical Corp.
Oct 2, 2014	Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M...	Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ...	Class III	Valeant Pharmaceuticals International
Oct 1, 2014	Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manuf...	Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.	Class III	Zydus Pharmaceuticals USA Inc
Oct 1, 2014	Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Man...	Defective Container; leaking around the cap	Class II	Gilead Sciences, Inc.
Oct 1, 2014	HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTAB...	Crystallization: Formation of crystals observed in product.	Class II	Avella of Deer Valley, Inc.
Oct 1, 2014	Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a)...	Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials th...	Class II	Hospira Inc.
Sep 30, 2014	Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) table...	Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.	Class III	Gilead Sciences, Inc.
Sep 29, 2014	DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, ...	Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during t...	Class II	Baxter Healthcare Corp.
Sep 26, 2014	Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/cart...	Failed Dissolution Specification; at the 6-month stability time point	Class II	Forest Pharmaceuticals Inc
Sep 26, 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles...	Failed Dissolution Specifications; 12 month stability time point	Class II	Sun Pharma Global Inc.
Sep 26, 2014	Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c...	Failed Tablet/Capsule Specifications: Presence of split or broken tablets.	Class II	Actavis Laboratories, FL, Inc.
Sep 24, 2014	BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured...	Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsu...	Class III	Zydus Pharmaceuticals USA Inc
Sep 22, 2014	CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufa...	CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not ...	Class II	Physicians Total Care, Inc.
Sep 22, 2014	LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufact...	Failed Content Uniformity Specifications; Dry mix failed blend uniformity.	Class II	Micro Labs Usa, Inc ...
Sep 18, 2014	E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c...	Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.	Class III	Bracco Diagnostic Inc
Sep 17, 2014	Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manu...	Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamin...	Class II	Janssen Ortho L.L.C.
Sep 15, 2014	CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 C...	Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.	Class II	AbbVie Inc
Sep 15, 2014	Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pai...	Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and disso...	Class II	American Family Pharmacy, LLC
Sep 15, 2014	TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila...	Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.	Class II	Zydus Pharmaceuticals USA Inc
Sep 15, 2014	Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ...	Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso...	Class II	Astellas Pharma US Inc
Sep 12, 2014	Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, R...	Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled roo...	Class II	Mckesson
Sep 11, 2014	HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0....	Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ...	Class I	Hospira Inc.
Sep 11, 2014	MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)...	Subpotent; 6 month stability time point	Class III	Qualitest Pharmaceuticals
Sep 9, 2014	Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuj...	Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine...	Class II	Hospira Inc.
Sep 8, 2014	Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq...	Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject...	Class II	Baxter Healthcare Corp
Sep 5, 2014	Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx...	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing...	Class I	Pharmacy Creations
Sep 5, 2014	Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution...	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing...	Class I	Pharmacy Creations
Sep 5, 2014	Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharm...	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing...	Class I	Pharmacy Creations
Sep 5, 2014	Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Ph...	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing...	Class I	Pharmacy Creations
Sep 4, 2014	Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Fre...	Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown,...	Class II	Hospira Inc.
Aug 28, 2014	FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalm...	Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet t...	Class II	Fougera Pharmaceuticals Inc.
Aug 28, 2014	Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Onl...	Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uni...	Class II	Alvogen, Inc
Aug 28, 2014	Dermatend Original, mole, wart and skin tag remover, For external use only, I...	Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b...	Class II	Solace International Inc
Aug 28, 2014	Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingr...	Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b...	Class II	Solace International Inc
Aug 27, 2014	Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber gl...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable ...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL ...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostad...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Bacteriostatic water for injection packaged in an amber glass injectable vial...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectabl...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alpros...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.

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.