Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 7, 2025 | H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China wi... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walm... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 2, 2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 27, 2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... | Class I | Sandoz Inc |
| Jun 27, 2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... | Class I | Sandoz Inc |
| Jun 16, 2025 | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... | Class III | Qualgen, LLC |
| May 23, 2025 | Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per... | Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl... | Class II | Consumer Product Partners, 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 15, 2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), ... | Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are ... | Class II | Nubratori, Inc |
| Apr 9, 2025 | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens ... | Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products... | Class II | Cardinal Health Inc. |
| Mar 13, 2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Mar 7, 2025 | [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT... | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Class II | Consumer Product Partners, LLC |
| Feb 24, 2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... | Class III | Imprimis NJOF, LLC |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... | Class I | ICU Medical, Inc. |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... | Class I | ICU Medical, Inc. |
| Jan 17, 2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% z... | Labeling: Missing Label: The finished product potentially missing the labeling with the drug fac... | Class III | The W.S. Badger Company, Inc. |
| Dec 20, 2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... | Class I | ENDO USA, Inc. |
| Dec 18, 2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 18, 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... | CGMP Deviations | Class II | Eugia US LLC |
| Dec 18, 2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, M... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, In... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufacture... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma,... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufact... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Nov 26, 2024 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit co... | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product | Class II | Curium US, LLC |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 14, 2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... | Labeling: Not Elsewhere Classified - Wrong NDC number | Class III | Zydus Pharmaceuticals (USA) Inc |
| Oct 30, 2024 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... | Labeling: Missing Label | Class II | Baxter Healthcare Corporation |
| Oct 18, 2024 | Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... | Labeling: Label Mix-Up | Class II | AvKARE |
| Oct 18, 2024 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... | Labeling: Label Mix-Up | Class II | AvKARE |
| Sep 11, 2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 11, 2024 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients:... | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes ... | Class II | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Aug 20, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... | LABELING: LABEL MIX-UP. | Class III | Elevate Oral Care |
| Jul 18, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... | Label mix-up: Carton incorrectly labeled. | Class III | Granules Consumer Health Inc. |
| Jul 11, 2024 | Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... | Class I | Aurobindo Pharma USA Inc |
| Jul 10, 2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... | Class I | Endo Pharmaceuticals, Inc. |
| Jul 8, 2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... | Class I | Hikma Pharmaceuticals USA Inc. |
| Jun 26, 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET 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.