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 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.
Feb 22, 2017 Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Onl... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Sodium Phosphate 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 Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Onl... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Methohexital Sodium all strengths, all dosage forms and all packaging, Rx On... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all pac... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Heparin sodium 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 Labetalol 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 Rocuronium Bromide 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 Nalbuphine 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 Ondansetron 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 Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Ephedrine Sulfate 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 Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Sodium Citrate 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 Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx On... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Potassium Phosphate all strengths, all dosage forms and all packaging, Rx On... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Midazolam 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 Cardioplegic Solution Maintenance all strengths, all dosage forms and all pac... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Standard Starter TPN 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.
Feb 22, 2017 Amiodarone 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 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packagi... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Adenosine 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 Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dos... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Diltiazem 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 TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Ave... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Famotidine 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 Lidocaine 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 Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and a... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Norepinephrine Bitartrate 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 ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all p... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Magnesium Sulfate 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.

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.