Browse Drug Recalls
1,076 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,076 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 1,076 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 20, 2016 | Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (In... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Vo... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal In... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL T... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Co... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Wa... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | Class I | United Exchange Corporation |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Aug 23, 2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: ... | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out... | Class III | Stason Pharmaceuticals, Inc. |
| Aug 19, 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... | Class I | Impax Laboratories, Inc. |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per ... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Aug 3, 2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules p... | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Class II | Golden State Medical Supply Inc. |
| Jul 5, 2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chlorid... | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant cl... | Class II | Let's Talk Health, Inc. |
| Jun 28, 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... | Class III | Golden State Medical Supply Inc. |
| Jun 1, 2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... | Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. | Class II | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... | Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. | Class III | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| Mar 25, 2016 | All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RE... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDIN... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING ... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... | Non-Sterility: fungal contamination due to leaking containers. | Class I | B. Braun Medical Inc |
| Mar 25, 2016 | All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
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.