Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2016 | sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp condition... | Subpotent Drug: failed at the 3 and 6 month stability time points. | Class III | J. Strickland and Co |
| Feb 10, 2016 | Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (2... | Labeling: Label Mix-Up | Class III | Pfizer Inc |
| Feb 5, 2016 | Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Package... | CGMP Deviations: Cylinders filled using out of date gauges. | Class III | Medical Park Homecare, Inc |
| Feb 2, 2016 | Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect exp... | Class III | Hospira Inc. |
| Feb 2, 2016 | Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial... | Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrec... | Class III | Isomeric Pharmacy Solution, LLC |
| Jan 28, 2016 | Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... | Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 27, 2016 | Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 27, 2016 | Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only... | Failed Impurities/Degradation Specifications | Class III | Golden State Medical Supply Inc. |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di... | Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) | Class III | Amerisource Health Services |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 18, 2016 | Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL... | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... | Class III | Bausch & Lomb, Inc. |
| Jan 18, 2016 | Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only... | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... | Class III | Bausch & Lomb, Inc. |
| Jan 18, 2016 | Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24... | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... | Class III | Bausch & Lomb, Inc. |
| Jan 15, 2016 | Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Suppleme... | Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could... | Class III | Virtus Pharmaceuticals, Llc |
| Jan 14, 2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manu... | Failed Impurities/Degradation Specifications: Out of specification for a known degradant. | Class III | Zydus Pharmaceuticals USA Inc |
| Dec 31, 2015 | NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chlor... | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Class III | Pharmedium Services, LLC |
| Dec 31, 2015 | NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chlor... | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Class III | Pharmedium Services, LLC |
| Dec 31, 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Class III | Sandoz Inc |
| Dec 18, 2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softge... | Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. | Class III | National Vitamin Co Inc |
| Dec 17, 2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Suppl... | Defective Delivery System: Product may contain leaking capsules. | Class III | Virtus Pharmaceuticals, Llc |
| Dec 17, 2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f... | Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de... | Class III | Bio-pharm, Inc. |
| Dec 15, 2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl... | Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. | Class III | Morton Grove Pharmaceuticals, Inc. |
| Dec 8, 2015 | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Genzyme Corporation |
| Dec 7, 2015 | Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Ba... | Failed Impurities/Degradation Specifications; Impurity A | Class III | Lupin Pharmaceuticals Inc. |
| Dec 2, 2015 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... | Failed Dissolution Specification | Class III | Pfizer Inc. |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 6... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Onl... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Nov 19, 2015 | NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... | Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. | Class III | Teva Pharmaceuticals USA |
| Nov 10, 2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... | Labeling: Not elsewhere classified. NDC number is incorrect on the container. | Class III | Northwind Pharmaceuticals LLC |
| Nov 4, 2015 | Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 2, 2015 | Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Oct 30, 2015 | Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor ... | Failed Impurities/Degradation Specifications: Out of specifications results for impurities. | Class III | Avantor Performance Materials Inc |
| Oct 29, 2015 | EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx onl... | Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP mono... | Class III | PQ Corporation |
| Oct 26, 2015 | Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Par Pharmaceutical Inc. |
| Oct 26, 2015 | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Par Pharmaceutical Inc. |
| Oct 21, 2015 | Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, ... | Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was foun... | Class III | Breckenridge Pharmaceutical, Inc |
| Oct 21, 2015 | RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... | Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| Oct 20, 2015 | Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... | Labeling: Incorrect or Missing Lot AND/OR Exp Date. | Class III | Teva Pharmaceutical Industries |
| Oct 19, 2015 | HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 13, 2015 | Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H... | Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a... | Class III | Rx PAK |
| Oct 1, 2015 | Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a... | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... | Class III | Tribute Pharmaceuticals US Inc. |
| Oct 1, 2015 | Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... | Class III | Tribute Pharmaceuticals US 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.