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
Apr 19, 2013 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... Non-Sterility Class I Abrams Royal Pharmacy
Apr 17, 2013 NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible ... Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopene... Class II Unique Pharmaceutical, Ltd
Apr 15, 2013 Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 The firm is recalling all lots of sterile products compounded by the pharmacy... Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assura... Class II Apothecure, Inc
Mar 28, 2013 Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Prese... Lack of Assurance of Sterility; reports of adverse events after injection Class II NuVision Pharmacy, Inc.
Mar 4, 2013 Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 S... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Jan 23, 2013 Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf... Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ... Class III Mission Pharmacal Co
Jan 17, 2013 Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminat... Class II Humco Holding Group, Inc
Aug 15, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For ... Subpotent; fluocinolone acetonide. Class III Galderma Laboratories, L.P.
May 18, 2012 a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules bl... Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tada... Class I InSo-Independent Contractor for West Coast Nutr...
Apr 23, 2012 ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alc... Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material tha... Class II Carefusion 213, Llc
Mar 20, 2012 DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut... Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp... Class III Quadrant Chemical Corporation
Nov 8, 2011 ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative S... Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (op... Class II Carefusion 213, Llc
May 27, 2011 ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750m... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, Inc.
May 27, 2011 PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams P... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, Inc.
May 27, 2011 PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 8... Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. Class II A B Nutrition, 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.