Browse Drug Recalls

6,322 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,322 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 6,322 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120... 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 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 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 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
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
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 Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texa... 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 Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- ND... 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 Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-170... 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 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 Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2... Lack of Assurance of Sterility Class III Pharm D Solutions, LLC
Sep 10, 2018 Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolami... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
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 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 Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 6969... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, H... 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 Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Ho... 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 Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas -... 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 Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas -... 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.