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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.

Clear
DateProductReasonClassFirm
Apr 22, 2013 Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expir... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expira... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 d... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... Class II Legacy Pharmaceutical Packaging LLC
Apr 22, 2013 Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 d... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Meperidine 100mg/ml MDV, 5ml 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Lidocaine 2% Inj MDV, 20 ml 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutan... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 19, 2013 Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... Class III Novartis Consumer Health
Apr 19, 2013 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... Non-Sterility Class I Abrams Royal Pharmacy
Apr 19, 2013 GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufac... Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle... Class II Qualitest Pharmaceuticals
Apr 18, 2013 Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for S... Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 ... Class II Sandoz Incorporated
Apr 17, 2013 Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a divisi... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible ... Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopene... Class II Unique Pharmaceutical, Ltd
Apr 17, 2013 Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compoundi... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compo... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a divisio... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compou... Lack of Sterility Assurance Class II Axium Healthcare Pharmacy dba Balanced Solution...

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.