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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Mar 7, 2022 Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tai... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Re... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made C... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Mad... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Ro... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-via... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 m... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tail... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compoun... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Co... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Com... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperat... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperatur... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compo... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, R... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compo... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refr... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 4, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 t... Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts o... Class I Fresenius Kabi USA, LLC
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (N... Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli. Class I Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic... Class I Tennessee Technical Coatings, Corp.
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... Class II Tennessee Technical Coatings, Corp.
Mar 2, 2022 HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4... Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a... Class II Vi-Jon, Inc.
Mar 2, 2022 Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... Class II Golden State Medical Supply Inc.
Feb 28, 2022 PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... Failed Dissolution Specifications Class II The Harvard Drug Group
Feb 25, 2022 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... Lack of sterility assurance: leaking bags Class II B. Braun Medical, Inc.
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 24, 2022 hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... Class II The Harvard Drug Group
Feb 22, 2022 Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... CGMP deviations Class II Preferred Pharmaceuticals, Inc.
Feb 22, 2022 Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL p... Impurity failure at 0-time of the repackaged lot. Class II American Health Packaging
Feb 21, 2022 Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,... Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impuritie... Class II Morton Grove Pharmaceuticals, Inc.
Feb 18, 2022 All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ... CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Class II Dollar Tree Distribution, Inc.
Feb 17, 2022 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... Failed impurities/degradation specifications Class II Direct Rx
Feb 17, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... Class III Dr. Reddy's Laboratories, Inc.
Feb 16, 2022 Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%)... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 16, 2022 Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... cGmp Deviations Class II Macleods Pharma Usa 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.