Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

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DateProductReasonClassFirm
Mar 28, 2014 XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orl... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineerin... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongw... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 24, 2014 INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b)... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Class II Teva Pharmaceuticals USA
Mar 24, 2014 GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottl... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class II Teva Pharmaceuticals USA
Mar 24, 2014 METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In IN... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class II Teva Pharmaceuticals USA
Mar 24, 2014 INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In ... CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class II Teva Pharmaceuticals USA
Mar 21, 2014 ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, D... Non-sterility: due to a failed sterility test Class II Teva Pharmaceuticals USA
Mar 4, 2014 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bot... Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ... Class II Teva Pharmaceuticals USA
Mar 4, 2014 Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bot... Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ... Class II Teva Pharmaceuticals USA
Mar 4, 2014 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bot... Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain ... Class II Teva Pharmaceuticals USA
Feb 12, 2014 Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in P... Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Class II Teva Pharmaceuticals USA
Feb 12, 2014 Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-6... Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Class II Teva Pharmaceuticals USA
Feb 11, 2014 QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy... Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point Class III Teva Pharmaceuticals USA
Jan 24, 2014 Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Dis... CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved m... Class II Teva Pharmaceuticals USA
Jan 24, 2014 Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Onl... CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved... Class II Teva Pharmaceuticals USA
Jan 24, 2014 Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Su... CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate an... Class II Teva Pharmaceuticals USA
Jan 24, 2014 Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Di... CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved ... Class II Teva Pharmaceuticals USA
Dec 18, 2013 Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Man... Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp... Class II Teva Pharmaceuticals USA
Dec 18, 2013 Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured... Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp... Class II Teva Pharmaceuticals USA
Dec 11, 2013 HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TEC... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 4, 2013 Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 mete... Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aer... Class III Teva Pharmaceuticals USA
Nov 26, 2013 Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva ... Failed Tablet/Capsule Specifications: There is a potential for broken tablets. Class II Teva Pharmaceuticals USA
Nov 14, 2013 Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L... Failed Stability Specifications: this product is below specification for preservative content. Class III Teva Pharmaceuticals USA, Inc.
Nov 8, 2013 Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufacture... Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Val... Class II Teva Pharmaceuticals USA, Inc.
Nov 6, 2013 Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs ste... Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in... Class II Airgas Medical Services
Oct 24, 2013 Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe,... Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported thr... Class II Teva Pharmaceuticals USA
Oct 11, 2013 Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose ... Presence of Precipitate; precipitation of drug product Class II Teva Pharmaceuticals USA
Oct 10, 2013 Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Ra... Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and ... Class II Airgas Medical Services
Oct 7, 2013 Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules ... Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 m... Class II Amedra Pharmaceuticals LLC
Sep 13, 2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intrave... Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... Class II AmeriSource Bergen
Sep 13, 2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intrav... Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... Class II AmeriSource Bergen
Sep 6, 2013 Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berr... Presence of Foreign Substance: process-related particulates which may be associated with the raw ... Class II Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
Aug 13, 2013 CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medic... Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual... Class II Teva Pharmaceuticals USA, Inc.
Aug 6, 2013 Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, ... Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10... Class II Teva Pharmaceuticals USA, Inc.
Jul 23, 2013 Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactur... Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (H... Class II Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-41... Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin... Class III Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
May 28, 2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin... Failed Dissolution Specification; during stability testing Class II Teva Pharmaceuticals USA, Inc.
May 15, 2013 Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amin... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solutio... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health

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.