Browse Drug Recalls

52 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 52 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 52 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Sep 5, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Dec 20, 2024 Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... Class I ENDO USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... Class I Endo Pharmaceuticals, Inc.
Mar 4, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... Presence of Particulate Matter. Class I Par Sterile Products LLC
Jan 11, 2024 Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... Class II Par Sterile Products LLC
Mar 2, 2023 Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL correspon... Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification result... Class II Endo Pharmaceuticals, Inc.
Nov 10, 2022 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only... Failed Impurities/Degradation Specifications Class II Par Formulations Private Limited
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Mar 4, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 4, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Feb 22, 2022 Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... CGMP deviations Class II Preferred Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Nov 9, 2021 Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use,... Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during ... Class II PAR Sterile Products LLC
Mar 15, 2021 Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Aug 10, 2020 BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 Failed Impurity /Degradation Specifications Class II Par Pharmaceutical Inc.
Mar 30, 2020 Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph... Failed Impurities/Degradation Specification: Presence of unknown impurity observed. Class II Par Pharmaceutical Inc.
Mar 4, 2020 PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... Class III Par Pharmaceutical Inc.
Feb 10, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... Class III Par Pharmaceutical Inc.
Apr 30, 2019 Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product Class I Par Pharmaceutical, Inc.
Sep 6, 2018 Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30... Failed impurities/degradation specifications: Finished product contain a known product impurity a... Class III Par Pharmaceutical, Inc.
Aug 14, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... Supterpotent Drug Class II Mckesson Corporation
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products LLC
Oct 5, 2016 Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx... Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the ... Class II Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablet... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, ... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol table... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
May 28, 2016 Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 ... Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydro... Class III Par Pharmaceutical
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 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 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 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 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.
Feb 12, 2015 Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams ste... Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene Class II Par Pharmaceutical Inc.
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydro... Class II Par Pharmaceutical 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.