Browse Drug Recalls
2,193 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,193 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 2,193 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 28, 2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 28, 2016 | C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 6... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 11, 2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... | Failed Dissolution Specifications | Class II | Actavis Inc |
| Jun 30, 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... | Class II | Actavis Inc |
| Jun 27, 2016 | Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-c... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 t... | Failed Dissolution Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-cou... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-c... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 10, 2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 3, 2016 | Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Redd... | Failed impurities/degradation: out of specification result for impurity secorapamycin. | Class III | Dr. Reddy's Laboratories, Inc. |
| May 30, 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... | Class III | Prinston Pharmaceutical Inc |
| May 25, 2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... | Labeling: Incorrect or Missing Package Insert | Class III | Sandoz Inc |
| May 23, 2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 9, 2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufac... | Failed impurities/degradation specifications: Out of specification results noticed in related sub... | Class II | Zydus Pharmaceuticals USA Inc |
| May 2, 2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... | Class III | Sandoz, Inc |
| May 2, 2016 | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... | Class III | Sandoz, Inc |
| Apr 27, 2016 | Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled ... | Defective Delivery System; may have a low frequency assembly fault which may result in pens block... | Class II | Novo Nordisk Inc |
| Apr 27, 2016 | Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge... | Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ... | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Apr 22, 2016 | CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottl... | Failed impurities/degradation specification: An out of specification results has been determined ... | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 30, 2016 | Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr... | Failed Impurities/Degradation Specifications; 12 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 24, 2016 | Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b)... | Subpotent Drug | Class III | Biocon Inc |
| Mar 16, 2016 | Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL... | Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp... | Class III | Actavis Pharma Inc |
| Mar 14, 2016 | Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manuf... | Failed Impurities/Degradation Specifications | Class II | Impax Laboratories, Inc. |
| Mar 14, 2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manu... | Failed Impurities/Degradation Specifications | Class II | Impax Laboratories, Inc. |
| Mar 3, 2016 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle... | Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tigh... | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 10, 2016 | Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (2... | Labeling: Label Mix-Up | Class III | Pfizer Inc |
| Jan 14, 2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manu... | Failed Impurities/Degradation Specifications: Out of specification for a known degradant. | Class III | Zydus Pharmaceuticals USA Inc |
| Dec 31, 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Class III | Sandoz Inc |
| Dec 24, 2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufac... | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Class II | Macleods Pharma Usa Inc |
| Nov 4, 2015 | Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 28, 2015 | Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... | Defective Delivery System; potential to have inaccurate dosage delivery | Class I | Sanofi-Aventis U.S. LLC |
| Oct 28, 2015 | Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... | Defective Delivery System; potential to have inaccurate dosage delivery | Class I | Sanofi-Aventis U.S. LLC |
| Sep 9, 2015 | Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or I... | Subpotent Drug | Class III | Ferring Pharmaceuticals Inc |
| Sep 4, 2015 | Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distr... | Failed Dissolution Specifications: Failed 24 month dissolution testing. | Class II | Valeant Pharmaceuticals North America LLC |
| Aug 24, 2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distribu... | Labeling: Wrong Bar Code | Class II | C. O. Truxton |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count ... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count ... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged i... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count B... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, 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.