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Browse Drug Recalls

43 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 43 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 43 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 HCG Inj 500un/ml MDV, 5 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 Trimix Inj 4.25ml Form MDV 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 10mcg/ml MDV, 5ml 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 Trimix Inj 30:3:5 MDV, 10ml 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 Trimix Inj 30:1:40 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 Tobramycin Opth Soln 13mg/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 Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 9... 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 Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 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.

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.