Browse Drug Recalls
14,483 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,483 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 14,483 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2016 | progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room tempe... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx i... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit s... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, T... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit siz... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size,... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abb... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Comp... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size,... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compou... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx i... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL u... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abb... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit si... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 11, 2016 | Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by... | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... | Class II | Pfizer Inc. |
| Jan 11, 2016 | Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by... | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... | Class II | Pfizer Inc. |
| Jan 8, 2016 | Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HB... | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... | Class II | Perrigo Company PLC |
| Jan 8, 2016 | Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged w... | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... | Class II | Perrigo Company PLC |
| Jan 5, 2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and... | Lack of Assurance of Sterility: Failed preservative effectiveness test | Class II | Mayne Pharma Usa |
| Dec 29, 2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, ... | Lack of assurance of sterility | Class II | TexasStar Pharmacy |
| Dec 24, 2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufac... | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Class II | Macleods Pharma Usa Inc |
| Dec 24, 2015 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syr... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Dec 24, 2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 21, 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... | Failed Dissolution Specifications: low test results at the 18 month time-point | Class II | Teva North America |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 3, 2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2... | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la... | Class II | GlaxoSmithKline, LLC |
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.