Browse Drug Recalls
1,749 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,749 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 1,749 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), p... | 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 Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%)... | 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 | 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 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 | 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 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 | 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. |
| 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. |
| 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 |
| Dec 21, 2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per... | Microbial Contamination of Non-Sterile Product | Class I | Lohxa, LLC |
| Dec 15, 2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 6, 2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Valisa MFG LLC |
| Dec 3, 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... | Class I | Gilead Sciences, Inc. |
| Nov 30, 2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Nov 30, 2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Aroma Release Technologies Inc |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deo... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topica... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily,... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, ... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, To... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 19, 2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | American Screening LLC |
| Nov 17, 2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... | Chemical contamination: Presence of benzene | Class I | Blistex Inc |
| Nov 17, 2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... | Temperature Abuse; temperature excursion during shipping | Class I | Sandoz Inc |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | Class I | VIRGIN SCENT INC |
| Oct 19, 2021 | Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... | Presence of Particulate Matter: Identified as Glass Particles | Class I | MERCK SHARP & DOHME CORP |
| Oct 12, 2021 | Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... | Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Oct 12, 2021 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare 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.