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 |
|---|---|---|---|---|
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count B... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 3, 2015 | Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 30, 2015 | Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactur... | Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of ... | Class II | Unichem Pharmaceuticals Usa Inc |
| Jul 29, 2015 | Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Class II | Wockhardt Usa Inc. |
| Jul 29, 2015 | Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Class II | Wockhardt Usa Inc. |
| Jul 28, 2015 | Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Equaline Original Prescription Strength, loratadine orally disintegrating tab... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packag... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATIN... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-cou... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Dis... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablet... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets pe... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Oral... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, D... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged i... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jul 28, 2015 | Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jun 26, 2015 | Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Car... | Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. | Class II | Ranbaxy Inc. |
| Jun 15, 2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Com... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Co... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Comp... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Cent... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vi... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound C... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vial... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liber... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, L... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Comp... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial,... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Com... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Dr... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug C... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Li... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 ... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
| Jun 15, 2015 | Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Cent... | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... | Class II | Liberty Drug & Surgical |
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.