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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.

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DateProductReasonClassFirm
Aug 23, 2019 fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Ma... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, D... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Di... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count carto... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 21, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... Class III Macleods Pharma Usa Inc
Aug 7, 2019 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tube... Temperature Abuse: Complaints received of liquidy texture. Class III Glenmark Pharmaceuticals Inc., USA
Jul 29, 2019 Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A... Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054... Class III Aurobindo Pharma USA Inc.
Jul 24, 2019 C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Col... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Coloni... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx onl... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 I... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, an... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 23, 2019 Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-19... GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. Class II Glenmark Pharmaceuticals Inc., USA
Jul 19, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... Failed Dissolution Specifications Class II Ascend Laboratories LLC
Jul 17, 2019 Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottle... Subpotent Drug Class II ImprimisRx NJ
Jul 17, 2019 Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... Failed Dissolution Specifications Class II Macleods Pharma Usa Inc
Jul 17, 2019 Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, pack... Subpotent Drug Class II ImprimisRx NJ
Jul 16, 2019 Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: ... Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enume... Class II Bionpharma Inc.
Jul 11, 2019 Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-cou... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 25-count suppositories, Distribute... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals 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.