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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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DateProductReasonClassFirm
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 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 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 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 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 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 Cyclosporine/corn oil stock vehicle oil 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 Histamine 2.75 mg/mL injectable packaged in an amber glass injectable vial, M... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bot... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Chlorhexidine gluconate 0.02% opthalmic solution packaged in an opaque squeez... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Pilocarpine (PF) 0.25% opthalmic solution packaged in an opaque squeeze bottl... 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, 30 mg/2 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil... 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, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil)... 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 ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alpro... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hydroxocobalamin 5 mg/mL injectable packaged in an amber glass injectable via... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915... Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages test... Class II Sage Products Inc
Aug 27, 2014 Lidocaine 2% injectable packaged in an amber glass injectable vial, Martin Av... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bot... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass inj... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle ey... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Man... Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Class II Qualitest Pharmaceuticals
Aug 27, 2014 Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass inject... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque sq... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Quad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Trimethoprim/sulfadiazine excipient stock solution injection packaged in an a... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze b... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL v... 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, 30 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 Paraben water for injection packaged in a sterile 1000 mL clear bottle, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Dexamethasone sodium phosphate 24 mg/mL injectable packaged in an amber glass... 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 T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chl... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Glycerin 72% (w/v) sodium chloride injectable packaged in an amber glass inje... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dro... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Mar... 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/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packag... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hydroxocobalamin 10 mg/mL injectable packaged in an amber glass injectable vi... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 PGE 4, 300 mcg/mL injectable packaged in a clear glass injectable vial, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Methylcobalamin (PF) 25 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 Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle e... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syrin... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable via... 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 T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate,... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Testosterone cypionate 150 mg/mL injection packaged in an amber glass inject... 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 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesy... 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.