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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.