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 28, 2026 | CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewab... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-co... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chew... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS,... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewabl... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-c... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 27, 2026 | Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg... | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specif... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 27, 2026 | Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pha... | Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as A... | Class II | Ajanta Pharma USA Inc |
| May 27, 2026 | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Di... | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio... | Class II | Lannett Company Inc. |
| May 22, 2026 | Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPh... | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 22, 2026 | Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPh... | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 22, 2026 | Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters... | Microbial contamination of sterile products | Class II | Zep Inc |
| May 21, 2026 | Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Con... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry F... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ ... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Fl... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Fl... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), ... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 19, 2026 | Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net ... | cGMP deviations | Class II | Shimoga Chemicals |
| May 18, 2026 | PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PR... | Lack of Assurance of Sterility | Class II | PReye LLC |
| May 18, 2026 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compou... | Subpotent Drug | Class II | IntegraDose Compounding Services LLC |
| May 18, 2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Class III | Eugia US LLC |
| May 18, 2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... | Failed Stability Specifications | Class III | AbbVie Inc. |
| May 15, 2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams ... | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Class II | PAI Holdings LLC |
| May 15, 2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams A... | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Class II | PAI Holdings LLC |
| May 15, 2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams ... | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Class II | PAI Holdings LLC |
| May 15, 2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams A... | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Class II | PAI Holdings LLC |
| May 14, 2026 | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius... | Failed Impurities/Degradations Specifications | Class III | Fresenius Kabi USA, LLC |
| May 14, 2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Asclemed USA Inc. |
| May 14, 2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distribu... | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex... | Class III | AVEVA Drug Delivery Systems, Inc. |
| May 12, 2026 | DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL singl... | Presence of Particulate matter: Particulate matter identified as glass. | Class I | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 12, 2026 | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distribut... | Lack of Assurance of Sterility | Class II | Spectra Medical Devices, Llc |
| May 12, 2026 | Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx on... | Defective Container; packets were found to be either empty or partially full. | Class II | ANI Pharmaceuticals, Inc. |
| May 12, 2026 | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Wate... | Subpotent Drug | Class II | IntegraDose Compounding Services LLC |
| May 11, 2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, War... | Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labe... | Class II | Haleon US Holdings LLC |
| May 8, 2026 | cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), R... | Lack of Assurance of Sterility | Class II | UCB Biosciences Inc. |
| May 5, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bott... | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications | Class II | Ascend Laboratories, LLC |
| May 4, 2026 | Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials,... | Failed Impurities/Degradation Specifications | Class III | Sagent Pharmaceuticals |
| May 1, 2026 | Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Con... | Presence of a Foreign Substance; black particles observed in liquid | Class II | Safecor Health, LLC |
| May 1, 2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Amerisource Health Services LLC |
| May 1, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Amerisource Health Services LLC |
| Apr 30, 2026 | Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are ... | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg ... | Class II | Safecor Health, LLC |
| Apr 29, 2026 | Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactur... | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Apr 29, 2026 | Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactur... | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Apr 29, 2026 | Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by... | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... | Class II | Ajanta Pharma Ltd. |
| Apr 29, 2026 | Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by... | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... | Class II | Ajanta Pharma Ltd. |
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.