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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
Dec 17, 2020 Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single D... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CI... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 5... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Onl... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmace... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pha... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class III SCA Pharmaceuticals
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
Oct 5, 2020 BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL sy... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... Non-Sterility Class I Med Shop Total Care Inc.
Aug 6, 2020 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville

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.