Browse Drug Recalls

1,723 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,723 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 1,723 FDA drug recalls — Class I.

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DateProductReasonClassFirm
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 13, 2022 CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon F... Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of G... Class I Vi-Jon, LLC
Jun 10, 2022 Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en ... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class I Latin Foods Market
Jun 9, 2022 SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, ... Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain ... Class I Green Pharmaceuticals, Inc.
Jun 8, 2022 Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Cod... Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain ... Class I Buzzagogo, LLC
Jun 7, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
May 26, 2022 Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bott... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class I Amazon.com, Inc.
May 26, 2022 Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, ... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class I Amazon.com, Inc.
May 26, 2022 Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton cont... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class I Amazon.com, Inc.
May 24, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles,... Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofen... Class I Walmart Inc
May 23, 2022 Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Su... Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). Class I Akcea Therapeutics, Inc.
May 11, 2022 Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... Class I Teva Pharmaceuticals USA Inc
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 12, 2022 Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), pac... Labeling: Missing label on the vial Class I Mylan Pharmaceuticals Inc
Apr 5, 2022 Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... Class I Cardinal Health Inc.
Mar 30, 2022 Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chloro... Chemical contamination: presence of benzene Class I Unilever United States Inc.
Mar 29, 2022 The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Be... Chemical Contamination; FDA analysis found product to contain benzene Class I Best Brands Consumer Products, Inc.
Mar 29, 2022 Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best B... Chemical Contamination; FDA analysis found product to contain methanol Class I Best Brands Consumer Products, Inc.
Mar 29, 2022 IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ... Presence of Particulate Matter: Product was found to contain silica and iron oxide Class I Teva Pharmaceuticals USA Inc
Mar 29, 2022 Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manu... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... Class I Pink Toyz
Mar 24, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Mar 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Mar 21, 2022 SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled ... Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... Class I Adamis Pharmaceuticals Corporation
Mar 21, 2022 SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled... Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... Class I Adamis Pharmaceuticals Corporation
Mar 8, 2022 Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... Class I Jubilant Cadista Pharmaceuticals, 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 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 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.
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 Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packag... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 16, 2022 Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), p... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 11, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... Non-sterility; bacterial contamination identified as Paenibacillus lautus. Class I Revive Rx LLC dba Revive Rx Pharmacy
Feb 10, 2022 RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton,... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Positive Health
Feb 9, 2022 Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Cap... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I Walmart Stores
Feb 8, 2022 THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Your Favorite Shop
Feb 8, 2022 MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLD... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tad... Class I Celebrate Today
Feb 4, 2022 MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... Class I Junp Hydration LLC
Feb 4, 2022 PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... Non-sterility Class I CooperSurgical, Inc
Feb 3, 2022 Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose ... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.
Feb 3, 2022 HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Do... Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... Class I STAQ Pharma, Inc.
Jan 28, 2022 HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per... Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed... Class I Esupplementsales, LLC
Jan 26, 2022 Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot Class I AuroMedics Pharma LLC
Jan 25, 2022 REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transfo... Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated... Class I Blaine Labs Inc
Jan 5, 2022 Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pe... Labeling: Missing Label: label missing from some Semglee prefilled pens. Class I Mylan Pharmaceuticals 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.