Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2018 | All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... | Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... | Class I | Bayer HealthCare Pharmaceuticals, Inc. |
| Mar 8, 2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... | Class I | Jimmy Weber |
| Feb 14, 2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural ... | Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence... | Class I | Bella All Natural |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer Inc. |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer Inc. |
| Jan 26, 2018 | Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 26, 2018 | Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 26, 2018 | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 26, 2018 | Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 17, 2018 | Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... | Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... | Class I | Magno Humphries Laboratories, Inc |
| Jan 12, 2018 | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,... | Non-Sterility | Class I | The Compounding Pharmacy of America |
| Jan 12, 2018 | Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... | Presence of Particulate Matter; contains visible particulate matter identified as mold. | Class I | AuroMedics Pharma LLC |
| Jan 5, 2018 | MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... | Subpotent | Class I | Advanced Pharma Inc. |
| Jan 4, 2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... | Class I | International Laboratories, LLC |
| Jan 2, 2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in... | Presence of Particulate Matter: A confirmed customer report was received for the presence of visi... | Class I | Aurobindo Pharma Ltd. |
| Dec 20, 2017 | Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use ... | Presence of Particulate Matter; white particulate matter identified as mold was found in one bag | Class I | AuroMedics Pharma LLC |
| Dec 7, 2017 | BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-cou... | Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibut... | Class I | BotanicalNow |
| Dec 4, 2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,... | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) ... | Class I | AuroMedics Pharma LLC |
| Nov 29, 2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long B... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sil... | Class I | Blue Fusion Natural |
| Nov 19, 2017 | Hard Times For Men capsules, packaged in a 23-count box of blister packs cont... | Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredie... | Class I | www.blankterrmall.com |
| Nov 10, 2017 | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... | Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of... | Class I | Baxter Healthcare Corporation |
| Nov 9, 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Class I | Kareway Products Inc |
| Oct 27, 2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... | Class I | Fresenius Kabi USA, LLC |
| Oct 20, 2017 | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m... | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent | Class I | Pfizer Inc. |
| Sep 20, 2017 | Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-s... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. | Class I | Natures Supplement |
| Sep 15, 2017 | grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... | Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which i... | Class I | Baxter Healthcare Corporation |
| Sep 15, 2017 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 5, 2017 | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... | Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. | Class I | Genentech, Inc. |
| Aug 30, 2017 | Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... | Presence of Particulate Matter: glass particulate found in vial | Class I | Pfizer Inc. |
| Aug 29, 2017 | PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, ... | Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. | Class I | Lucky Mart Inc. |
| Aug 7, 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... | Class I | International Laboratories, Inc. |
| Aug 3, 2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Class I | Amneal Pharmaceuticals of New York, LLC |
| Aug 1, 2017 | NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count p... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... | Class I | The Ampt Life, LLC |
| Jul 24, 2017 | LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by L... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... | Class I | EZWeightLossTX LLC |
| Jul 24, 2017 | LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by La... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... | Class I | EZWeightLossTX LLC |
| Jul 21, 2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in ... | Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil a... | Class I | Chiavna Saffron LLC |
| Jul 17, 2017 | New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red pac... | Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclar... | Class I | BESTHERBS COFFEE LLC |
| Jul 5, 2017 | D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore For... | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | Class I | HARDCORE FORMULATIONS |
| Jul 5, 2017 | ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcor... | Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. | Class I | HARDCORE FORMULATIONS |
| Jun 22, 2017 | MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sild... | Class I | Vitility |
| Jun 9, 2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 6, 2017 | ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu... | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Class I | Andropharm, LLC |
| Jun 6, 2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and... | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Class I | Andropharm, LLC |
| Jun 5, 2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... | Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... | Class I | Bristol-myers Squibb Company |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... | Class I | Teva Pharmaceuticals |
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.