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Browse Drug Recalls

514 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 514 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 514 FDA drug recalls in AZ.

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DateProductReasonClassFirm
Jan 16, 2026 Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repac... Subpotent Drug Class II Specialty Process Labs LLC
Dec 8, 2025 ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, S... cGMP Deviations Class II Signature Formulations, LLC
Dec 8, 2025 ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, ... cGMP Deviations Class II Signature Formulations, LLC
Jun 2, 2025 LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infil... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow I... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRIN... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
Jun 2, 2025 KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Sl... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
May 21, 2025 UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... Class I Umary-USA.com
May 21, 2025 UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... Class I Umary-USA.com
Apr 14, 2025 Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distr... Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... Class I SAINI TRADE INC
Apr 14, 2025 MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distr... Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... Class I SAINI TRADE INC
Apr 14, 2025 Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: He... Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... Class I SAINI TRADE INC
Apr 14, 2025 ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Dist... Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... Class I SAINI TRADE INC
Apr 14, 2025 ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health... Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... Class I SAINI TRADE INC
Nov 6, 2024 BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syr... Lack of Sterility Assurance Class II Tailstorm Health INC
Jul 3, 2024 Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:20... Subpotent Drug: reduced efficacy for epinephrine Class II TAILSTORM HEALTH INC
Mar 1, 2024 S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or R... Failed Stability Specifications Class II Specialty Process Labs LLC
Mar 1, 2024 S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging... Failed Stability Specifications Class II Specialty Process Labs LLC
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, tota... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Cent... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volum... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCI... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, P... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag,... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repac... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syri... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Ce... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Exce... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 m... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCI... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx O... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with *... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High P... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total V... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total V... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag,... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEP... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, 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.