Browse Drug Recalls
14,396 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,396 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 14,396 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 23, 2016 | Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per ca... | Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were... | Class II | TMIG 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. |
| Mar 23, 2016 | PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. ... | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... | Class II | Akorn, Inc. |
| Mar 23, 2016 | ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (47... | Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... | Class II | Akorn, Inc. |
| Mar 14, 2016 | Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratori... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 m... | Lack of Assurance of Sterility: incomplete or missing data regarding production. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manu... | Failed Impurities/Degradation Specifications | Class II | Impax Laboratories, Inc. |
| Mar 14, 2016 | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manuf... | Failed Impurities/Degradation Specifications | Class II | Impax Laboratories, Inc. |
| Mar 14, 2016 | Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... | Superpotent Drug: one ingredient was found to be above assay specification. | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 8, 2016 | Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 8, 2016 | Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 8, 2016 | Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 8, 2016 | Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 8, 2016 | Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 8, 2016 | Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos... | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... | Class II | Hospira Inc. |
| Mar 3, 2016 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle... | Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tigh... | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 1, 2016 | Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing... | Cross contamination with other products: metronidazole | Class II | Sagent Pharmaceuticals Inc |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo... | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Class II | Genzyme Corporation |
| Feb 16, 2016 | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo... | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Class II | Genzyme Corporation |
| Feb 12, 2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl... | Failed Dissolution Specifications; three month stability time point. | Class II | Mylan Pharmaceuticals Inc. |
| Feb 12, 2016 | Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bo... | Lack of Assurance of Sterility | Class II | Walter's Pharmacy |
| Feb 12, 2016 | Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N ... | Lack of Assurance of Sterility | Class II | Walter's 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.