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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
Apr 20, 2016 HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pha... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syr... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Ca... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Com... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compoun... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Com... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD s... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Phar... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syr... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Comp... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoje... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Comp... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Comp... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compo... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Feb 11, 2016 Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, t... Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of m... Class I Pharmakon Pharmaceuticals
Nov 10, 2015 Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... Labeling: Not elsewhere classified. NDC number is incorrect on the container. Class III Northwind Pharmaceuticals LLC
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Tot... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 1... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosag... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syri... Subpotent drug. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Subpotent drug. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals
Aug 19, 2015 Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Stability data does not support expiry. Class II Pharmakon Pharmaceuticals

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.