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
Aug 27, 2014	Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injecta...	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 T25, 4.413 mg/0.145 mg/1.475 mcg/mL (papaverine, phentolamine mesylat...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 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	Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injec...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amb...	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ...	Class II	Martin Avenue Pharmacy, Inc.
Aug 27, 2014	Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injecta...	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.
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	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	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	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	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	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 25, 2014	Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only...	Subpotent Drug	Class II	Actavis Inc
Aug 25, 2014	Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only...	Subpotent Drug	Class II	Actavis Inc
Aug 25, 2014	Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, ...	Failed Content Uniformity Specifications.	Class III	Taro Pharmaceuticals U.S.A., Inc.
Aug 21, 2014	Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count...	Failed Impurity/Degradation Specification; high out of specification for CAD II degradant	Class III	Apotex Corp.
Aug 20, 2014	CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeu...	Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.	Class III	ChiroNutraceutical LLC
Aug 19, 2014	Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: ...	Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy ...	Class III	Micro Labs Usa, Inc ...
Aug 19, 2014	Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ...	Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te...	Class III	Perrigo Holland Inc
Aug 13, 2014	PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx o...	CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several cr...	Class II	Fresenius Kabi USA, LLC
Aug 13, 2014	METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), ...	Defective Container: Product leaks when inverted.	Class II	VistaPharm, Inc.
Aug 8, 2014	CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only,...	Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at th...	Class I	Cubist Pharmaceuticals, Inc.
Aug 7, 2014	MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product p...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a p...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro...	Presence of Particulate Matter: particulate matter was found during the manufacturing process.	Class I	Baxter Healthcare Corp.
Aug 7, 2014	Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. ...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due t...	Class II	New Gpc Inc.
Aug 7, 2014	WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic ...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 6, 2014	Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white spr...	Microbial Contamination of Non-Sterile Product	Class II	HLI dba Humphreyline Inc
Aug 6, 2014	CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingred...	Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop...	Class II	Qualitest Pharmaceuticals
Aug 6, 2014	CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active i...	Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop...	Class II	Qualitest Pharmaceuticals
Aug 6, 2014	CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingre...	Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop...	Class II	Qualitest Pharmaceuticals
Aug 5, 2014	Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass...	Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im...	Class III	Akorn, Inc.
Aug 5, 2014	ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufacture...	Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were notic...	Class II	Zydus Pharmaceuticals USA Inc
Aug 4, 2014	ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container ...	Presence of Particulate Matter: identification of particulates in a retention sample that have be...	Class II	Baxter Healthcare Corp
Aug 1, 2014	CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact...	Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.	Class I	Cubist Pharmaceuticals, Inc.
Jul 31, 2014	CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx o...	Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container clo...	Class II	Ben Venue Laboratories Inc
Jul 30, 2014	Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: S...	Presence of Foreign Substance; tablets may contain stainless steel metal particulates	Class II	Mckesson Packaging Services
Jul 30, 2014	0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte...	Lack of Assurance of Sterility; complaints of mold in the overpouch	Class II	Baxter Healthcare Corp.
Jul 30, 2014	Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL...	Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a...	Class III	Pfizer Inc.
Jul 30, 2014	Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M...	Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making...	Class III	Novartis Pharmaceuticals Corp.
Jul 29, 2014	Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl...	Presence of Particulate Matter: The product was discolored and contained visible particulates (ir...	Class I	Hospira Inc.
Jul 28, 2014	OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl...	Failed Stability Specifications: Out of specification result for preservative sodium benzoate.	Class III	Boehringer Ingelheim Roxane Inc
Jul 25, 2014	Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeto...	Presence of Foreign Substance; tablets may contain stainless steel metal particulates	Class II	Sandoz Incorporated
Jul 24, 2014	Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-c...	Failed Dissolution Specifications: Dissolution failures found during testing of control samples a...	Class II	Wockhardt Usa Inc.
Jul 24, 2014	Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescr...	Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence...	Class II	Fagron, Inc
Jul 24, 2014	Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For pr...	Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence...	Class II	Fagron, 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.