Browse Drug Recalls
2,097 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,097 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 2,097 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 7, 2024 | Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... | Presence of foreign substance. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 4, 2024 | Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... | Subpotent Drug | Class II | Teva Pharmaceuticals USA, Inc |
| Jun 4, 2024 | Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... | Failed Impurities/Degradation Specifications: Related Substances | Class III | Dr. Reddy's Laboratories, Inc. |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| May 28, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... | Defective Container | Class III | Organon Llc |
| May 23, 2024 | Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... | Lack of Assurance of Sterility: Leaking vials | Class II | Dr. Reddy's Laboratories, Inc. |
| May 23, 2024 | Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL ... | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phos... | Class II | Eugia US LLC |
| May 22, 2024 | Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mf... | Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide... | Class III | Eugia US LLC |
| May 16, 2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manuf... | Failed Impurities/Degradation Specifications. | Class III | Zydus Pharmaceuticals (USA) Inc |
| May 16, 2024 | Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Risin... | Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Pack... | Class III | Rising Pharma Holding, Inc. |
| May 16, 2024 | Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufa... | Failed Impurities/Degradation Specifications. | Class III | Zydus Pharmaceuticals (USA) Inc |
| 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 14, 2024 | Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| 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 14, 2024 | Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intra... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraoc... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Pres... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| 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 | 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 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 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 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. |
| 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 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 | 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 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 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 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 17, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 10, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... | Out of specification for assay | Class III | Imprimis NJOF, LLC |
| Apr 10, 2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... | Subpotent Drug | Class II | Imprimis NJOF, LLC |
| Apr 8, 2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Apr 8, 2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Mar 28, 2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 26, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 26, 2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... | Class II | Cipla USA, Inc. |
| Mar 25, 2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... | Failed Impurities/Degradation Specifications | Class III | Novitium Pharma LLC |
| Mar 12, 2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... | The filter included in the carton has an expiration date that has expired prior to the expiration... | Class II | Hikma Pharmaceuticals USA Inc. |
| Mar 7, 2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 4, 2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... | Cross Contamination with Other Products:(mycophenolate mofetil). | Class III | Novitium Pharma LLC |
| Mar 4, 2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES 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.