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.

Clear
DateProductReasonClassFirm
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 PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
Mar 24, 2014 PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex 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 Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, ... Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... Class II Apotex Inc.
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 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... Class III Apotex Inc.
Mar 18, 2014 Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: ... Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign mater... Class II Glenmark Generics Inc., USA
Mar 17, 2014 Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Mar 17, 2014 Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pha... Presence of Particulate Matter Class II John W Hollis Inc
Mar 17, 2014 Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, N... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class II John W Hollis Inc
Mar 17, 2014 Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Ph... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Mar 14, 2014 VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/via... Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. Class I Shire Human Genetic Therapies, Inc.
Mar 13, 2014 Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufacture... Defective container: Product distributed without inner seal on bottles. Class II Blu Pharmaceuticals Inc
Mar 13, 2014 REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los hue... Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Class I Pain Free By Nature
Mar 13, 2014 Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured... Defective container: Product distributed without inner seal on bottles. Class II Blu Pharmaceuticals Inc
Mar 11, 2014 Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5m... Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochlo... Class II Paddock Laboratories, LLC
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defe... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Admini... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 6, 2014 Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a... Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg ca... Class I Pfizer Us Pharmaceutical Group
Mar 6, 2014 Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottl... Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and ide... Class I Greenstone Llc
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
Mar 4, 2014 Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag... Lack of Assurance of Sterility; leaking of premix bags Class II Sagent Pharmaceuticals Inc
Mar 4, 2014 VIVITROL (naltrexone for extended-release injectable suspension); 380 mg via... Customer complaints for failure to deliver the dose. Class II Alkermes, Inc.
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, 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 3, 2014 Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC On... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Mad... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. Class III McKesson Packaging Services
Mar 3, 2014 Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OT... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made ... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Ma... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Med... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC O... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicin... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only... Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... Class III Novartis Pharmaceuticals Corp.
Mar 3, 2014 Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OT... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC ... Penicillin Cross Contamination. Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Coug... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made... Penicillin Cross Contamination Class II Terra-Medica Inc.
Mar 3, 2014 Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC ... Penicillin Cross Contamination Class II Terra-Medica 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.