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 28, 2021 | Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... | Failed Impurities/Degradation Specifications | Class III | Teva Pharmaceuticals USA |
| Oct 27, 2021 | Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx... | Labelling: Incorrect Exp. Date | Class II | Teva Pharmaceuticals USA |
| Oct 25, 2021 | Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Nor... | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 25, 2021 | Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Nort... | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 25, 2021 | Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... | Discoloration | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Oct 22, 2021 | Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Ph... | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 19, 2021 | Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... | Presence of Particulate Matter: Identified as Glass Particles | Class I | MERCK SHARP & DOHME CORP |
| Oct 19, 2021 | Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... | Defective Container | Class II | Teligent Pharma, Inc. |
| Oct 19, 2021 | Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... | Defective Container | Class II | Teligent Pharma, Inc. |
| Oct 18, 2021 | Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 18, 2021 | Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 18, 2021 | Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 12, 2021 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... | CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... | Class II | Teligent Pharma, Inc. |
| Oct 12, 2021 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... | CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... | Class II | Teligent Pharma, Inc. |
| Oct 12, 2021 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottle... | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole... | CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, P... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, pa... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a)... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... | cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots w... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 O... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dis... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 13... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 O... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, lab... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Sep 28, 2021 | The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL O... | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Men... | Class II | Revive Personal Products Company |
| Sep 27, 2021 | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 9, 2021 | Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only... | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specificatio... | Class I | Jacobus Pharmaceutical Company 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.