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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
Oct 10, 2025 Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... Failed Dissolution Specifications Class II Lannett Company Inc.
Aug 20, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength ... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... Class II Northwind Pharmaceuticals LLC
Aug 19, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... Class II Lannett Company Inc.
Aug 11, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... Class II Lannett Company Inc.
Oct 25, 2024 Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only... Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified... Class II Lannett Company Inc.
Mar 12, 2024 Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... CGMP Deviations Class II Eli Lilly & Company
Mar 16, 2023 Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackag... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repac... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Mar 16, 2023 Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-8... CGMP Deviations Class II Northwind Pharmaceuticals LLC
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Sep 24, 2021 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per ... SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. The... Class I Eli Lilly & Company
Aug 19, 2021 Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,... Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL act... Class II Eli Lilly & Company
Jun 29, 2021 Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cak... Class II Eli Lilly & Company
Nov 30, 2020 PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, India... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular ... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, India... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianap... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, ... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicin... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular M... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medic... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, I... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Ind... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indi... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 30, 2020 BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, I... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Advanced Nutriceuticals, LLC
Nov 19, 2020 Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-D... CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product f... Class II Areva Pharmaceuticals Inc
Feb 21, 2019 Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... Failed Dissolution Specifications Class III Lannett Company Inc.
Nov 8, 2018 ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... Labeling: Missing label; potential for missing primary container label on the vial. Class III Eli Lilly & Co
Jul 18, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Dec 2, 2016 Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, pa... Subpotent Drug Class III Ecolab, Inc.
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by P... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compo... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Mon... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, C... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKO... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Br... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, 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.