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 |
|---|---|---|---|---|
| Jul 14, 2017 | Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg ... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose S... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmace... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutic... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dos... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmac... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe,... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-D... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag ... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Pre... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free ... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 6, 2017 | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxt... | Lack of Assurance of Sterility: Bags have the potential to leak. | Class II | Baxter Healthcare Corporation |
| Jul 6, 2017 | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxte... | Lack of Assurance of Sterility: Bags have the potential to leak. | Class II | Baxter Healthcare Corporation |
| Jul 6, 2017 | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Ba... | Lack of Assurance of Sterility: Customer complaints for leaking bags. | Class II | Baxter Healthcare Corporation |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL i... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in ... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL i... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Int... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 15... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 2... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 15... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intrav... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intrav... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL In... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 26, 2017 | Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 15... | Lack of Assurance of Sterility; media fill failure at manufacturer | Class II | PharMedium Services, Llc |
| Jun 22, 2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 19, 2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only.... | Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier | Class II | Fagron Compounding Services LLC dba Fagron Ster... |
| Jun 16, 2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 16, 2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 16, 2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 15, 2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 1, 2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 ... | Lack of Assurance of Sterility | Class II | MedPark Pharmacy, LLC |
| May 18, 2017 | HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Vo... | Lack of assurance of sterility: Product bags leaking at seam. | Class II | SCA Pharmaceuticals |
| May 18, 2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... | Lack of assurance of sterility: Product bags leaking at seam. | Class II | SCA Pharmaceuticals |
| May 18, 2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total ... | Lack of assurance of sterility: Product bags leaking at seam. | Class II | SCA 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.