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 14, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 13, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Golden State Medical Supply Inc. |
| May 13, 2024 | Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Mult... | Subpotent product in addition to having out-of-specification results for impurities. | Class II | American Regent, Inc. |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufact... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... | Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Preferred Pharmaceuticals, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufa... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 8, 2024 | Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx... | Defective container: lack of seal integrity. | Class II | Lupin Pharmaceuticals Inc. |
| May 7, 2024 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-c... | Presence of foreign substance: plastic-like substance. | Class II | MACLEODS PHARMA USA, INC |
| May 7, 2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... | Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. | Class II | PACIRA PHARMACEUTICALS INC |
| May 6, 2024 | Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distribute... | Presence of Foreign Substance: metal in tablet | Class II | Rubicon Research Private Limited |
| May 2, 2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3... | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported findin... | Class II | RemedyRepack Inc. |
| May 1, 2024 | Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. ... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| May 1, 2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| May 1, 2024 | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| Apr 30, 2024 | Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl... | Failed Impurities/Degradation Specifications | Class II | Viatris Inc |
| Apr 30, 2024 | Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl... | Failed Impurities/Degradation Specifications | Class II | Viatris Inc |
| Apr 30, 2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged... | Labeling: Wrong Barcode | Class III | Hikma Injectables USA Inc |
| Apr 29, 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. | Class I | Hikma Injectables USA Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 29, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Apr 26, 2024 | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri... | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t... | Class II | Rubicon Research Private Limited |
| Apr 25, 2024 | MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 m... | Presence of Particulate Matter: Potential for black particulates in the drug product. | Class II | Sagent Pharmaceuticals |
| Apr 25, 2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... | Class II | FDC Limited |
| Apr 25, 2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ... | Class III | Viatris Inc |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 24, 2024 | Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... | Presence of Foreign Substance; Broken metal piece found embedded in tablet. | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Apr 24, 2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle... | Subpotent drug | Class III | Acella Pharmaceuticals, LLC |
| Apr 24, 2024 | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC... | Discoloration: Dotted and yellow spots on tablets | Class II | Aurobindo Pharma USA Inc. |
| Apr 24, 2024 | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vial... | Presence of Foreign Substance: This oil based product may contain trace amounts of water for inje... | Class II | SOMERSET THERAPEUTICS LLC |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 24, 2024 | Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC ... | Discoloration: Dotted and yellow spots on tablets | Class II | Aurobindo Pharma USA Inc. |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... | Lack of Assurance of Sterility: Complaints of syringe breakage | Class II | Regeneron Pharmaceuticals Inc |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, N... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 22, 2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... | Marketed Without An Approved NDA/ANDA | Class I | Stop Clopez Corp |
| Apr 22, 2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... | Failed Release Testing: Out of specification for particulate matter test. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 20, 2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Class I | Revive Rx LLC dba Revive Rx Pharmacy |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: S... | Out of specification for assay | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax 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.