Browse Drug Recalls
702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 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 702 FDA drug recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 5, 2016 | Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By... | Failed Impurities/Degradation Specifications: Out of specification test results for impurities du... | Class II | Teva Pharmaceuticals USA |
| Dec 23, 2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufac... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured f... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| Dec 23, 2015 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for... | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... | Class I | Bee Xtreme |
| 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 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. |
| 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 12, 2015 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... | Failed Impurities/Degradation Specifications: High out of specification test result for impuritie... | Class II | Teva Pharmaceuticals USA |
| Nov 11, 2015 | Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| Nov 11, 2015 | Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In... | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... | Class II | RemedyRepack Inc. |
| 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 9, 2015 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH... | Presence of foreign substance -This recall has been intiated due to the presence of a polyethylen... | Class II | Mutual Pharmaceutical Company, Inc. |
| Aug 6, 2015 | LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged ... | Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. | Class I | Blue Square Market, Inc. |
| Aug 6, 2015 | KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 str... | Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. | Class I | Blue Square Market, Inc. |
| Jul 24, 2015 | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x... | Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution | Class I | Teva Pharmaceuticals USA |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 15, 2015 | SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (1... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, Sou... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tub... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 ... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufacture... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured ... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 14, 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott... | Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown... | Class III | KVK-Tech, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jun 30, 2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9... | Failed Dissolution Specifications | Class III | GlaxoSmithkline Consmer Healthcare |
| Jun 30, 2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu... | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob... | Class II | Mylan Pharmaceuticals Inc |
| Jun 24, 2015 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: out of specification for unknown impurity | Class II | Teva Pharmaceuticals USA |
| May 20, 2015 | Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only,... | Failed Dissolution Specifications: Low out of specification dissolution results. | Class II | Mylan Lab Inc |
| May 11, 2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: OOS result during stability testing | Class II | Teva Pharmaceuticals USA |
| May 7, 2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For... | Failed Impurities/Degradation Specifications: out of specification test results for an impurity d... | Class III | Teva Pharmaceuticals USA |
| Apr 28, 2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In... | Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ... | Class I | Teva Pharmaceuticals USA |
| Apr 23, 2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside ... | Crystallization | Class II | RemedyRepack Inc. |
| Apr 13, 2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured b... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Apr 13, 2015 | Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-6... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Mar 10, 2015 | Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by... | Failed Impurities/Degradation Specifications: during long-term stability testing. | Class II | Mutual Pharmaceutical Company, Inc. |
| Feb 18, 2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside... | Crystallization | Class II | RemedyRepack 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.