Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 6, 2021 | Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Nov 30, 2021 | 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... | Lack of sterility assurance: bag has the potential to leak. | Class II | Pfizer Inc. |
| Nov 17, 2021 | Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 12, 2021 | EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Tal... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, T... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx o... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Ph... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, T... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pha... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABL... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, R... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
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.