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 |
|---|---|---|---|---|
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 50 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, 60 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 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 23, 2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. ... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- B... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 21, 2025 | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (1... | Lack of Assurance of Sterility. | Class II | Bristol-Myers Squibb Company |
| Oct 21, 2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed b... | Defective Container | Class II | Kenvue Brands LLC |
| Oct 20, 2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emu... | Subpotent Drug | Class III | Imprimis NJOF, LLC |
| Oct 13, 2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg... | Subpotent drug; Clavulanate Potassium component | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 9, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51... | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Class II | Breckenridge Pharmaceutical, Inc. |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl... | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ... | Class II | Rising Pharma Holding, Inc. |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... | Class II | Heritage Pharmaceuticals Inc |
| Oct 6, 2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
| Oct 1, 2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu... | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind... | Class II | Church & Dwight Co., Inc. |
| Sep 26, 2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative co... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 24, 2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydu... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 24, 2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zy... | Failed impurity/degradation specifications:Out of Specification result for an individual organic ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-51... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 6787... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Sep 17, 2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... | CGMP Deviations: Market complaints received for gritty texture (grainy) | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 5, 2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... | cGMP deviations: Temperature excursion during transportation. | Class II | Sandoz Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus L... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lif... | Failed Impurity/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... | Failed Impurities/Degradation Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufacture... | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium T... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 3, 2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable ... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 28, 2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by:... | Superpotent drug | Class II | Ascend Laboratories, LLC |
| Aug 27, 2025 | DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
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.