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