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.

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DateProductReasonClassFirm
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.