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Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Jul 24, 2014 Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescri... Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence... Class II Fagron, Inc
Jul 24, 2014 Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administra... Non-Sterility: The recalled lot failed sterility testing. Class I Physician Preferred Medical, LLC
Jul 18, 2014 Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP... CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Class II Spectrum Laboratory Products
Jul 18, 2014 All sterile products within expiry Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices t... Class II Unique Pharmaceutical, Ltd
Jul 18, 2014 N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. Class I Unique Pharmaceutical, Ltd
Jul 17, 2014 Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... Class III X-Gen Pharmaceuticals Inc.
Jul 17, 2014 Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I... CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Class II SST Corporation
Jul 16, 2014 Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Ch... Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspens... Class II Bio-pharm, Inc.
Jul 15, 2014 Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Jul 14, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzo... Class III Wockhardt Usa Inc.
Jul 12, 2014 Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufac... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg,... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 3... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 m... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bot... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 11, 2014 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 11, 2014 Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics Class I Baxter Healthcare Corp.
Jul 11, 2014 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 11, 2014 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tabl... Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. Class II Jubilant Cadista Pharmaceuticals Inc.
Jul 11, 2014 Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class III Sandoz Inc
Jul 10, 2014 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... Class I Hospira Inc.
Jul 9, 2014 Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for ... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medici... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medi... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 9, 2014 Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Prep... cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... Class II Gyma Laboratories Of Amer,Inc
Jul 8, 2014 VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... Class III Pfizer Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermat... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatol... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 3, 2014 Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, R... Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and ... Class II Mylan Pharmaceuticals Inc.
Jul 2, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... Class III Bracco Diagnostic Inc
Jul 1, 2014 Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jul 1, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jun 27, 2014 fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable ba... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag,... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chlori... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), ... Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Class II Hospira Inc.
Jun 26, 2014 LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guai... Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... Class III Poly Pharmaceuticals, Inc
Jun 26, 2014 POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Ma... Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... Class III Poly Pharmaceuticals, Inc
Jun 26, 2014 Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 26, 2014 Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 25, 2014 G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ... Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t... Class II Medical Supply Liquidators Llc
Jun 25, 2014 Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, ... Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t... Class II Medical Supply Liquidators Llc
Jun 25, 2014 BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM ... Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t... Class II Medical Supply Liquidators Llc
Jun 25, 2014 Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For I... Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t... Class II Medical Supply Liquidators 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.