Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 21, 2025 | Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per ca... | cGMP Deviations | Class II | YANGZHOU YULOU PAPER PRODUCTS CO., LTD |
| Jul 15, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 11, 2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Nostrum Laboratories, Inc. |
| Jul 10, 2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jun 30, 2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 22, 2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com ... | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet dis... | Class II | Aurobindo Pharma USA Inc |
| 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 9, 2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd.... | cGMP deviations | Class II | KVK Tech, Inc. |
| May 9, 2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only,... | cGMP deviations | Class II | KVK Tech, Inc. |
| 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 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 | Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Fl... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| 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 | 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 | 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 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 | Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by... | 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 | Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesi... | 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 | Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint... | 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 | 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 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 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 | 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 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 | 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 |
| Apr 21, 2025 | BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-10... | CGMP Deviations; potential temperature excursions due to transit delays | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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 18, 2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... | cGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 15, 2025 | Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed b... | cGMP deviations | Class II | Pharmadel, LLC |
| Apr 15, 2025 | DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharm... | cGMP deviations | Class II | Pharmadel, LLC |
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.