Browse Drug Recalls

972 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 972 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 972 FDA drug recalls in TX.

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DateProductReasonClassFirm
May 17, 2018 Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guard... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardi... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compound... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridger... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian P... Lack of sterility assurance. Class II Guardian Pharmacy Services
Jan 5, 2018 MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... Subpotent Class I Advanced Pharma Inc.
Dec 12, 2017 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 ... Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burk... Class II Woodfield Pharmaceutical, LLC
Dec 7, 2017 BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-cou... Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibut... Class I BotanicalNow
Oct 19, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... Failed Impurities/Degradation Specifications. Class III Allergan Sales, LLC
Oct 19, 2017 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... Failed Impurities/Degradation Specifications. Class III Allergan Sales, LLC
Oct 6, 2017 A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottl... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sib... Class II Kiriko, LLC.
Aug 30, 2017 Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Mid Valley Pharmaceutical
Aug 30, 2017 Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Mid Valley Pharmaceutical
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

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.