Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 17, 2020 | morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), R... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
| Dec 17, 2020 | SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dos... | 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 | 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 | 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 | 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 | 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 | fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 ... | 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 500 mcg/5mL in 0.9% Sodium Chloride (100 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 | 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 | Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1m... | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Class II | Imprimis NJOF, LLC |
| Dec 17, 2020 | HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx... | 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 | Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA P... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
| Dec 17, 2020 | Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
| Dec 17, 2020 | Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Sing... | 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 | Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx On... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
| Dec 17, 2020 | fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 |
| 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 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... | 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 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... | 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 | 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 | 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 | 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 | HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| 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 | BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... | 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. |
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.