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.

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DateProductReasonClassFirm
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.