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 |
|---|---|---|---|---|
| Oct 6, 2014 | HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Co... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, R... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wil... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 ... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Co... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 ... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, R... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wi... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, R... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creat... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vi... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compou... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Co... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, ... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wil... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creat... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syri... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds,... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml gla... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compo... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, ... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bot... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, C... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compound... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass ... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative C... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.2... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Cre... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bot... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Comp... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 6, 2014 | SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, R... | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not... | Class II | Oregon Compounding Centers, Inc. dba Creative C... |
| Oct 1, 2014 | Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a)... | Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials th... | Class II | Hospira Inc. |
| Sep 29, 2014 | DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, ... | Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during t... | Class II | Baxter Healthcare Corp. |
| Sep 5, 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Ph... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharm... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Sep 5, 2014 | Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx... | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... | Class I | Pharmacy Creations |
| Aug 27, 2014 | Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alpr... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an ambe... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Benzalkonium chloride water for injection packaged in an amber glass injectab... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass inje... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, Inc. |
| Aug 27, 2014 | Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Av... | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... | Class II | Martin Avenue Pharmacy, 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.