Browse Drug Recalls
1,198 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,198 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 1,198 FDA drug recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Class I | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE CO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELI... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PH... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/REL... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUN... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx ... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... | Class III | Bryant Ranch Prepack Inc. |
| Mar 25, 2016 | All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPO... | 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 |
| 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 ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... | 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 propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... | 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 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 lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE... | 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 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 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 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 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 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 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 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 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 methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... | 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 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 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 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 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 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 diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... | 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 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 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 baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
| Mar 24, 2016 | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for Abb... | Failed Content Uniformity Specifications | Class III | AbbVie Inc. |
| Mar 24, 2016 | Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:... | Labeling: Incorrect or Missing Lot and/or Expiration Date | Class III | Lupin Limited |
| 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 23, 2016 | Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PE... | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... | Class II | Akorn, 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.