Browse Drug Recalls
2,091 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,091 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 2,091 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Feb 26, 2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 18, 2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 10, 2026 | Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single d... | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo... | Class II | LEO PHARMA INC |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets b... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, R... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 27, 2026 | Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharma... | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] resul... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 21, 2026 | Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed b... | Tablets/Capsules Imprinted with Wrong ID | Class III | Unichem Pharmaceuticals USA Inc. |
| Jan 21, 2026 | Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100... | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | Class II | Unichem Pharmaceuticals USA Inc. |
| Jan 15, 2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton cont... | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blis... | Class II | Greenstone Llc |
| Jan 2, 2026 | Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep ... | Presence of Particulate Matter. | Class II | Cipla USA, Inc. |
| Dec 31, 2025 | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,... | Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets ... | Class II | Alvogen, Inc |
| Dec 30, 2025 | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by... | Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsule... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Dec 30, 2025 | Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Dec 30, 2025 | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 26, 2025 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex... | Class III | Haleon US Holdings LLC |
| Dec 22, 2025 | Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. ... | CGMP Deviations: product found to contain lead. | Class I | HANDELNINE GLOBAL LLC |
| Dec 22, 2025 | Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... | Failed PH Specifications | Class III | Cipla USA, Inc. |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, ... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Ma... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 19, 2025 | traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on ... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Dec 18, 2025 | Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 15, 2025 | Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactur... | Failed Impurities/Degradation Specifications | Class III | NOVADOZ PHARMACEUTICALS LLC |
| Nov 26, 2025 | Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applica... | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Nov 21, 2025 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 18, 2025 | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... | Cross Contamination with Other Products | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 11, 2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... | Defective Container - A defect in the side-seal which allows leakage of product. | Class III | Teva Pharmaceuticals USA, Inc |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | 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.