Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... | cGMP deviations | Class II | Amerisource Health Services LLC |
| May 14, 2025 | Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inh... | Defective delivery system | Class II | AsttraZeneca Pharmaceuticals LP |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 13, 2025 | Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only,... | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was ... | Class II | AvKARE |
| May 13, 2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 9, 2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd.... | cGMP deviations | Class II | KVK Tech, Inc. |
| May 9, 2025 | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alemb... | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a ... | Class II | Alembic Pharmaceuticals Limited |
| May 9, 2025 | Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per car... | Failed Dissolution Specifications | Class II | AvKARE |
| May 9, 2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only,... | cGMP deviations | Class II | KVK Tech, Inc. |
| May 7, 2025 | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufac... | Failed Impurities/Degradation Specifications | Class II | Alembic Pharmaceuticals Limited |
| May 6, 2025 | ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA... | Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and... | Class I | EnShiShiXiangNiShangMaoYouXianGongSi |
| May 2, 2025 | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Mult... | Lack of Assurance of Sterility | Class II | Empower Clinic Services, LLC dba Empower Pharmacy |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Co... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcu... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by:... | CGMP Deviations | Class II | Siddha Flower Essences, LLC. |
| Apr 25, 2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Sin... | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 25, 2025 | Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) an... | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 24, 2025 | KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulf... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - ... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Fl... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%,... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%,... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesi... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 23, 2025 | Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromello... | cGMP deviations and lack of assurance of sterility. | Class II | BRS Analytical Services, LLC |
| Apr 23, 2025 | Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodiu... | cGMP deviations and lack of assurance of sterility. | Class II | BRS Analytical Services, LLC |
| Apr 23, 2025 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulos... | cGMP deviations and lack of assurance of sterility. | Class II | BRS Analytical Services, LLC |
| Apr 23, 2025 | Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Pro... | cGMP deviations and lack of assurance of sterility. | Class II | BRS Analytical Services, LLC |
| Apr 23, 2025 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing... | cGMP deviations and lack of assurance of sterility. | Class II | BRS Analytical Services, LLC |
| Apr 22, 2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. | Class II | RemedyRePack Inc. |
| Apr 21, 2025 | Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-d... | Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... | Class II | Eugia US LLC |
| Apr 21, 2025 | EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use O... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 21, 2025 | Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose... | Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... | Class II | Eugia US LLC |
| Apr 21, 2025 | PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, M... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
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.