Browse Drug Recalls
2,191 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,191 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 2,191 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 14, 2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... | Class II | Ascend Laboratories, LLC |
| Mar 14, 2023 | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... | Class II | Ascend Laboratories, LLC |
| Mar 13, 2023 | Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... | Class I | Camber Pharmaceuticals Inc. |
| Mar 9, 2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 24, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Feb 23, 2023 | Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 22, 2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 17, 2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Akron Pharma, Inc. |
| Feb 15, 2023 | Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... | Failed Impurities/Degradation Specifications | Class II | RISING PHARMACEUTICALS |
| Feb 8, 2023 | Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... | Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bot... | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 6, 2023 | Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Ma... | Sub-Potent Drug: Out of specification for assay at the 24 month interval. | Class II | Alvogen, Inc |
| Feb 2, 2023 | Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... | Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. | Class III | Advantice Health, Llc |
| Jan 31, 2023 | Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manuf... | Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. | Class II | BIOCON PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouch... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouch... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouch... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouch... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pou... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pou... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pou... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pou... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouch... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 30, 2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouc... | Subpotent Drug | Class II | IBSA PHARMA INC |
| Jan 17, 2023 | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... | Class II | Fisher Scientific Co., LLC |
| Jan 17, 2023 | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... | Class II | Fisher Scientific Co., LLC |
| Jan 13, 2023 | Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... | Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 5, 2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... | Class III | MACLEODS PHARMA USA, INC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Dec 28, 2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on th... | Class II | Ascend Laboratories, LLC |
| Dec 28, 2022 | Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial | Class II | Eugia US LLC |
| Dec 19, 2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles... | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... | Class I | Spectrum Laboratory Products, Inc. |
| Dec 19, 2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va... | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... | Class I | Spectrum Laboratory Products, Inc. |
| Dec 16, 2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 16, 2022 | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro... | Failed Impurities/Degradation Specifications | Class II | Aurolife Pharma, LLC |
| Dec 6, 2022 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| 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 |
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.