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.

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DateProductReasonClassFirm
Dec 13, 2013 Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... Failed Dissolution Specification; 12-Month stability interval. Class II Dr. Reddy's Laboratories, Inc.
Dec 9, 2013 Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND... Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial... Class II Actavis Inc
Nov 27, 2013 Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle,... Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit ... Class II Wockhardt Usa Inc.
Nov 15, 2013 BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. Class III Actavis Inc
Nov 7, 2013 Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... Class II West-Ward Pharmaceutical Corp.
Nov 6, 2013 Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... Class II Actavis Elizabeth LLC
Nov 5, 2013 sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Dist... Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36... Class II Greenstone LLC
Nov 4, 2013 Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... Class III Greenstone Llc
Nov 1, 2013 Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, ... Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Exten... Class II Greenstone Llc
Oct 10, 2013 Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.Bell... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaVi... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, ... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count ... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, w... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 9, 2013 Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ... Class II Sandoz, Inc
Oct 9, 2013 Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Onl... Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below sp... Class II Actavis Elizabeth LLC
Oct 7, 2013 Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturi... CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current g... Class II Betachem, Inc.
Sep 30, 2013 G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b... Failed Content Uniformity Specifications; at the 18 month time point. Class III G & W Laboratories Inc
Sep 27, 2013 Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 1... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... Class I Haute Health, LLC
Sep 27, 2013 PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and ... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... Class I Haute Health, LLC
Sep 27, 2013 Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 caps... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingred... Class I Haute Health, LLC
Sep 23, 2013 Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Sep 23, 2013 Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Sep 20, 2013 Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in... Class III Valeant Pharmaceuticals North Am
Sep 19, 2013 ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Man... Discoloration; due to prolonged heat exposure. Class III Ferring Pharmaceuticals Inc
Sep 11, 2013 Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J... Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril... Class II Janssen Pharmaceuticals, Inc.
Sep 4, 2013 Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By:... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Greenstone Llc
Sep 4, 2013 Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By:... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Greenstone Llc
Aug 29, 2013 IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05)... Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an inco... Class II Dr. Reddy's Laboratories, Inc.
Aug 26, 2013 EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Cr... Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection... Class II Pharmacy Creations
Aug 26, 2013 Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations... Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection... Class II Pharmacy Creations
Aug 2, 2013 Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... Class II Dr. Reddy's Laboratories, Inc.
Jul 31, 2013 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... Class III Actavis Inc
Jul 30, 2013 Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (N... Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other U... Class II West-Ward Pharmaceutical Corp.
Jul 30, 2013 Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10... Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets Class II West-Ward Pharmaceutical Corp.
Jul 19, 2013 Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... Class III Bracco Diagnostics Inc
Jul 2, 2013 Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured a... Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out ... Class II Core Pharma Llc
Jun 21, 2013 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37... Presence of foreign substance: One lot of the product may contain black foreign particles Class II Bracco Diagnostics Inc
Jun 13, 2013 Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... Failed Stability Specifications: Out of specification results for particle size were obtained at ... Class III Bayer HealthCare Pharmaceuticals Inc.
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 4, 2013 VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl... Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification resu... Class II West-Ward Pharmaceutical Corp.
May 31, 2013 Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... Failed Dissolution Specification Class III Pfizer Inc
May 21, 2013 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization; crystallized nimodipine Class II Sun Pharmaceutical Industries Inc.
May 17, 2013 Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician S... Failed Impurities/Degradation Specifications: unspecified degradation product Class II Warner Chilcott US LLC
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe... Class II West-Ward Pharmaceutical Corp.

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.