Browse Drug Recalls
17,551 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,551 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 17,551 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 25, 2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... | CGMP Deviations | Class II | Alpha Aromatics |
| Jan 25, 2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 23, 2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... | Class II | Baxter Healthcare Corporation |
| Jan 22, 2024 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... | Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... | Class II | IntegraDose Compounding Services LLC |
| Jan 19, 2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | CGMP Deviations | Class II | OMEZA LLC |
| Jan 18, 2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 17, 2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... | Class II | Henry Schein Inc. and Glove Club HSI Gloves Inc. |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Class II | Ascend Laboratories, LLC |
| Jan 16, 2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 15, 2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, ... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Di... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wi... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 7... | Subpotent Drug | Class II | IntegraDose Compounding Services LLC |
| Jan 12, 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Jan 11, 2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... | Failed Impurities/Degradation Specification. | Class II | Amerisource Health Services LLC |
| Jan 11, 2024 | Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... | Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... | Class II | Par Sterile Products LLC |
| Jan 10, 2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe... | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 10, 2024 | Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... | Lack of Sterility Assurance: Aseptic process simulation failure. | Class II | BE PHARMACEUTICALS AG |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 5, 2024 | Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 5, 2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 4, 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... | Labeling: Label Mix-up | Class I | Azurity Pharmaceuticals, Inc. |
| Jan 4, 2024 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill v... | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 3, 2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... | Failed Impurities/Degradation Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2024 | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 29, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bo... | Presence of Foreign Tablets/Capsules | Class II | Rising Pharma Holding, Inc. |
| Dec 29, 2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: St... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Dec 29, 2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle... | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an ... | Class II | Ascend Laboratories, LLC |
| Dec 28, 2023 | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
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.