Browse Drug Recalls

953 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 953 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 953 FDA drug recalls in TX.

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DateProductReasonClassFirm
Aug 1, 2017 NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count p... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... Class I The Ampt Life, LLC
Jul 24, 2017 LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by La... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... Class I EZWeightLossTX LLC
Jul 24, 2017 LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by L... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... Class I EZWeightLossTX LLC
Jul 17, 2017 New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red pac... Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclar... Class I BESTHERBS COFFEE LLC
Jul 5, 2017 ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcor... Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. Class I HARDCORE FORMULATIONS
Jul 5, 2017 D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore For... Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. Class I HARDCORE FORMULATIONS
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in ... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Int... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 2... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL In... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
May 25, 2017 CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufa... Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, t... Class I Brian P. Richardson
May 5, 2017 GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA anal... Class I Genetic Edge Compounds LLC
May 1, 2017 Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... Class II Allergan Sales, LLC
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, Llc
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, Llc
Mar 28, 2017 LaBri's Body Health Atomic, 60 capsules Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. Class I Envy Me
Mar 16, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... Failed Impurities/Degradation Specifications Class III Allergan Sales, LLC
Feb 22, 2017 Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, A... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avell... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packag... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx O... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma 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.