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 |
|---|---|---|---|---|
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 13, 2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast S... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 4, 2023 | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 3, 2023 | Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular... | Subpotent: Failing Test Results for Epinephrine | Class III | Imprimis NJOF, LLC |
| Sep 28, 2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... | Class II | Eugia US LLC |
| Sep 25, 2023 | BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufact... | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate d... | Class I | Scynexis, Inc. |
| Sep 21, 2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 20, 2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O... | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%... | Class III | Imprimis NJOF, LLC |
| Sep 8, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Class I | Novartis Pharmaceuticals Corp. |
| Sep 8, 2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Class I | Church & Dwight Inc |
| Sep 7, 2023 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent: Out of Specification result observed for low assay | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Aug 29, 2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 9... | Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packag... | Class III | RB Health (US) LLC |
| Aug 14, 2023 | Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 ... | Subpotent: Out of Specification for Assay Test at the 3-month time point. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Aug 10, 2023 | Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottl... | Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. | Class III | Imprimis NJOF, LLC |
| Aug 10, 2023 | hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v f... | Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons label... | Class II | Colgate Palmolive Company |
| Aug 7, 2023 | PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injec... | Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot num... | Class III | Advanced Accelerator Applications USA, Inc. |
| Aug 2, 2023 | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... | Failed dissolution specifications - results obtained were below spec average. | Class II | Aurobindo Pharma USA Inc. |
| Aug 2, 2023 | Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-0... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 307... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Jul 27, 2023 | Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured fo... | Failed Impurities/Degradation Specifications | Class III | ALEMBIC PHARMACEUTICALS, INC. |
| Jul 21, 2023 | Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... | cGMP deviations: Batch was released prior to approval. | Class II | Aurobindo Pharma USA Inc. |
| Jul 21, 2023 | Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... | cGMP deviations: Batch was released prior to approval. | Class II | Aurobindo Pharma USA Inc. |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... | Class III | Ascend Laboratories, LLC |
| Jul 18, 2023 | Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured b... | Out of Specification result observed in content uniformity testing | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 13, 2023 | Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot... | Presence of Foreign Substance: Metal embedded in a tablet. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 11, 2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Jul 10, 2023 | Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Ph... | Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 5, 2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ... | Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 5, 2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B... | Failed Moisture Limits: Water (moisture) content above the approved product specifications. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 27, 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... | Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall... | Class I | Cipla USA, Inc. |
| Jun 26, 2023 | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, ... | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Class II | Strides Pharma Inc. |
| Jun 23, 2023 | Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac... | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Class II | Kramer Laboratories, Inc. |
| Jun 23, 2023 | Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress... | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Class II | Kramer Laboratories, Inc. |
| Jun 22, 2023 | Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles... | Defective Delivery System | Class II | ALEMBIC PHARMACEUTICALS, INC. |
| Jun 12, 2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products | Class II | Ferring Pharmaceuticals Inc |
| May 30, 2023 | Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun... | Subpotent drug | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 22, 2023 | Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged ... | Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for... | Class II | Aurobindo Pharma USA Inc. |
| May 18, 2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by... | Failed Impurities/Degradation Specifications | Class III | Aurolife Pharma, LLC |
| May 11, 2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... | Failed Impurities/Degradation Specifications: Out-of-specification results for total related comp... | Class II | Hikma Pharmaceuticals USA Inc. |
| May 9, 2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... | Failed Dissolution Specifications; during stability testing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 3, 2023 | Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... | CGMP Deviations | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 1, 2023 | Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed ... | Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an... | Class II | Glenmark Therapeutics, Inc. |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA 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.