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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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.

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DateProductReasonClassFirm
Nov 19, 2018 Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Pharm D Solutions, LLC
Nov 5, 2018 puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... Non-Sterility: Product manufactured under non-sterile production conditions. Class I Kadesh International
Oct 31, 2018 BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n... Lack of Assurance of Sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 29, 2018 Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in... Defective Container: vial defect was identified that could potentially impact the container closu... Class II GE Healthcare Inc. Life Sciences
Oct 19, 2018 Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Ave... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 19, 2018 Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Oct 17, 2018 Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-1... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 c... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (ND... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-18... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-0... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-11... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 15, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Class II Heritage Pharmaceuticals, Inc.
Oct 8, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 8, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Sep 19, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... Class II Pfizer Inc.
Sep 10, 2018 Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, T... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texa... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas ---... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- N... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Hou... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC

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.