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 |
|---|---|---|---|---|
| Dec 6, 2022 | Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Onl... | Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid c... | Class III | Camber Pharmaceuticals, Inc |
| Dec 1, 2022 | Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185... | Presence of foreign substance | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 23, 2022 | Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed b... | Subpotent Drug | Class II | Heritage Pharmaceuticals Inc |
| Nov 21, 2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 9, 2022 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, I... | Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. | Class II | ImprimisRx NJ |
| Oct 18, 2022 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx... | Presence of Foreign Substance | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 5, 2022 | Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Class II | Aurobindo Pharma USA Inc. |
| Sep 30, 2022 | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled... | Subpotent Drug: Out of specification for assay | Class II | AuroMedics Pharma LLC |
| Sep 29, 2022 | Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose... | Lack of Assurance of Sterility: environmental monitoring failure. | Class II | CIPLA |
| Sep 26, 2022 | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... | Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate fl... | Class II | AuroMedics Pharma LLC |
| Sep 26, 2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... | Presence of Particulate Matter: Piece of metal found in a vial | Class III | AuroMedics Pharma LLC |
| Sep 20, 2022 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec... | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride ... | Class III | QuVa Pharma, Inc. |
| Sep 19, 2022 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu... | Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Sep 16, 2022 | Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx... | CGMP deviations: Out of specification results obtained during routine stability testing for ethan... | Class II | Novartis Pharmaceuticals Corporation |
| Sep 15, 2022 | Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 ... | Lack of Assurance of Sterility | Class II | CIPLA |
| Sep 14, 2022 | Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... | Failed Stability Specifications: Out of specification results reported at 12-month stability test... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 29, 2022 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually... | Class II | Teva Pharmaceuticals USA Inc |
| Aug 23, 2022 | ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LE... | Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules | Class III | Leading Pharma, LLC |
| Aug 23, 2022 | Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... | CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... | Class II | Teva Pharmaceuticals USA Inc |
| Aug 22, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Aug 22, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Aug 4, 2022 | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-802... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 4, 2022 | Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle ... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 2, 2022 | Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... | Lack of Assurance of Sterility: Complaints received of defective container closure. | Class II | CIPLA |
| Jul 25, 2022 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in ... | Discoloration | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 22, 2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... | Class III | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ.... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 19, 2022 | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: St... | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Class II | Strides Pharma Inc. |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM B... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 15, 2022 | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jul 14, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... | Defective Container: Tube split from side seam | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 11, 2022 | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 29, 2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, R... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx ... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... | Failed Tablet/Capsule Specification : Capsule breakage | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 27, 2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... | cGMP - Water leakage | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 16, 2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... | Defective Container | Class III | Glenmark Pharmaceuticals Inc., USA |
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.