Browse Drug Recalls
17,709 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,709 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 17,709 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... | Class II | Amerisource Health Services LLC |
| Oct 9, 2025 | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bo... | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity... | Class II | USV Private Limited |
| Oct 9, 2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Techn... | Marketed Without an Approved NDA/ANDA | Class II | ibspot |
| Oct 9, 2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 8, 2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syring... | Lack of Assurance of Sterility: | Class II | ASTRAZENECA PHARMACEUTICALS |
| Oct 8, 2025 | Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Dist... | Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsul... | Class I | Mohamed Hagar |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl... | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ... | Class II | Rising Pharma Holding, Inc. |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
| 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... |
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.