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Browse Drug Recalls

208 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 208 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 208 FDA drug recalls in IN.

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DateProductReasonClassFirm
Aug 19, 2015 Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Jul 7, 2015 Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24... Class II Kremers Urban Pharmaceuticals, Inc.
Jul 7, 2015 Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity ... Class II Kremers Urban Pharmaceuticals, Inc.
Jun 4, 2015 Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor ach... Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of t... Class III Indiana Botanic Gardens, 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
Apr 21, 2014 Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharma... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class II Pharmakon Pharmaceuticals
Mar 26, 2014 Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per... Superpotent Drug: Product contains twice the stated amount of midazolam. Class I Pharmakon Pharmaceuticals
Sep 16, 2013 Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per b... Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not ... Class II Kremers Urban Pharmaceuticals, 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 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.

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.