Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 3, 2025 | TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only,... | Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. | Class II | Advanced Pharmaceutical Technology, Inc. |
| Oct 1, 2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dos... | Presence of Particulate Matter: Particulate matter identified as glass | Class II | Aspiro Pharma Limited |
| Oct 1, 2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu... | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind... | Class II | Church & Dwight Co., Inc. |
| Sep 29, 2025 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl A... | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... | Class II | Acuity Specialty Products, Inc. |
| Sep 29, 2025 | Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per... | Subpotent Drug | Class II | Medline Industries, LP |
| Sep 29, 2025 | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by... | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... | Class II | Acuity Specialty Products, Inc. |
| Sep 29, 2025 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution ... | Class II | Acella Pharmaceuticals, LLC |
| Sep 26, 2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative co... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 25, 2025 | Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, ... | cGMP deviations: the firm released and distributed product which failed total aerobic microbial c... | Class II | SV Labs Prescott Corporation |
| Sep 24, 2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydu... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 24, 2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zy... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 23, 2025 | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL b... | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. | Class II | Park Avenue Compounding |
| Sep 23, 2025 | Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Man... | Product Mix-up | Class II | ACME UNITED CORPORATION |
| Sep 22, 2025 | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Vo... | Lack of assurance of sterility. | Class II | RC Outsourcing, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-51... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 6787... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 17, 2025 | Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue... | CGMP Deviations | Class II | Park Avenue Compounding |
| Sep 17, 2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... | CGMP Deviations: Market complaints received for gritty texture (grainy) | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 16, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... | Class II | ACCORD HEALTHCARE, INC. |
| Sep 16, 2025 | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only... | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | Class I | IntegraDose Compounding Services LLC |
| Sep 15, 2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... | Failed Dissolution Specifications. | Class II | Amerisource Health Services LLC |
| Sep 15, 2025 | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count b... | Failed Tablet/Capsule Specifications | Class II | Graviti Pharmaceuticals Private Limited |
| Sep 12, 2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured... | Tablet/Capsules Imprinted with Wrong ID | Class III | JB Chemicals and Pharmaceuticals Ltd |
| Sep 12, 2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bli... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) b... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) ... | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 12, 2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Class III | Letco Medical LLC |
| Sep 12, 2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured... | Tablet/Capsules Imprinted with Wrong ID | Class III | JB Chemicals and Pharmaceuticals Ltd |
| Sep 12, 2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 5, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Sep 5, 2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... | cGMP deviations: Temperature excursion during transportation. | Class II | Sandoz Inc |
| Sep 5, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 5, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 4, 2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus L... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lif... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... | Failed Impurities/Degradation Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufacture... | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium T... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) 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.