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Browse Drug Recalls

29 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 29 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 29 FDA drug recalls.

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DateProductReasonClassFirm
Mar 3, 2026 Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... Class II Rising Pharma Holding, Inc.
Jan 10, 2026 Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Risi... Presence of Foreign Substance Class II Graviti Pharmaceuticals Private Limited
Jul 5, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Class II FDC Limited
Apr 18, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Jan 23, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Dec 5, 2024 Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx onl... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Nov 19, 2024 Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Oct 29, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Aug 12, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (ND... Defective Container: patients are unable to get the solution out of the bottle as the spike of th... Class II FDC Limited
Jul 18, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective container; yellow colored spike from cap lodged in the nozzle Class II FDC Limited
Jun 24, 2024 Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... Class III Rising Pharma Holding, Inc.
Apr 25, 2024 Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... Class II FDC Limited
Feb 15, 2023 Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... Failed Impurities/Degradation Specifications Class II RISING PHARMACEUTICALS
Feb 7, 2022 Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx ... Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufa... Class II RISING PHARMACEUTICALS
Sep 2, 2021 Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed ... Labeling: Incorrect Instructions Class II RISING PHARMACEUTICALS
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
May 21, 2019 Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
Mar 7, 2019 Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Mar 7, 2019 Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace... CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... Class II Rising Pharmaceuticals, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufac... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Jun 7, 2016 Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in... Subpotency: product assayed and found OOS for cyproheptadine Class III Lyne Laboratories, 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.