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 |
|---|---|---|---|---|
| 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 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram... | Class III | Reckitt Benckiser LLC |
| 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. |
| Aug 3, 2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets pe... | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of on... | Class II | Aurobindo Pharma USA Inc |
| Aug 2, 2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 2, 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 1, 2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... | Non-Sterility; microbial contamination identified as Bacillus circulans | Class I | Town and Country Compounding and Consultation S... |
| Aug 1, 2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical M... | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Class II | Spectrum Laboratory Products, Inc. |
| Aug 1, 2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension,... | Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate /... | Class II | Isomeric Pharmacy Solution, LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia ce... | Class I | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 28, 2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 28, 2016 | C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... | Class II | Colonia Care Pharmacy |
| Jul 27, 2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, ... | Failed impurities/degradation specifications: product was out of specification for unknown impuri... | Class III | Akorn, Inc. |
| Jul 26, 2016 | Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hat... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial,... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, ... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, cl... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, M... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, H... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostagla... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hatties... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hatt... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 3... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostagland... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compound... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesbur... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg,... | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 26, 2016 | Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Jul 25, 2016 | Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) ... | Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia | Class I | US Compounding Inc |
| Jul 21, 2016 | Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx O... | Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlargi... | Class I | Arbor Pharmaceuticals Inc. |
| Jul 19, 2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogena... | Lack of Assurance of Sterility | Class II | Talon Compounding Pharmacy |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 19, 2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 6... | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Class II | Zydus Pharmaceuticals USA Inc |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSm... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmi... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 18, 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoS... | Penicillin Cross Contamination | Class II | GlaxoSmithKline, LLC |
| Jul 15, 2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg p... | Failed Content Uniformity Specifications: out of specification test result for spray content unif... | Class III | Teva North America |
| Jul 15, 2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint ... | Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia | Class I | The Harvard Drug Group |
| Jul 12, 2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pac... | Superpotent Drug: Failure of assay specifications in the capsule. | Class II | Supernus 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.