Browse Drug Recalls

62 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 62 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 62 FDA drug recalls.

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DateProductReasonClassFirm
Feb 18, 2026 Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 18, 2026 Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Jan 2, 2026 Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep ... Presence of Particulate Matter. Class II Cipla USA, Inc.
Dec 22, 2025 Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... Failed PH Specifications Class III Cipla USA, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Nov 14, 2025 Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II Cipla USA, Inc.
Oct 31, 2025 Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carto... Failed Stability Specifications: Observed OOS results: eg results for colour index Class II Cipla Limited
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Jul 24, 2025 Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... Failed Stability Specifications: Out of specification results was observed in Induction Port duri... Class III Cipla USA, Inc.
Jun 30, 2025 Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class II Cipla USA, Inc.
Oct 23, 2024 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, Inc.
Oct 23, 2024 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, Inc.
Mar 26, 2024 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... Class II Cipla USA, Inc.
Dec 11, 2023 Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. Class II Legacy Pharmaceutical Packaging LLC
Nov 17, 2023 Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... Defective Container: powder may leak out of the pouch Class I InvaGen Pharmaceuticals, Inc.
Jun 27, 2023 Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall... Class I Cipla USA, Inc.
Sep 29, 2022 Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose... Lack of Assurance of Sterility: environmental monitoring failure. Class II CIPLA
Sep 15, 2022 Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 ... Lack of Assurance of Sterility Class II CIPLA
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 2, 2022 Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... Lack of Assurance of Sterility: Complaints received of defective container closure. Class II CIPLA
Jul 14, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Jan 26, 2022 Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jun 10, 2021 Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured... CGMP Deviations Class II CIPLA
Mar 15, 2021 Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactur... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
Jun 12, 2019 Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... Defective Container; actuator may improperly function and affect dose delivery. Class III InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Feb 1, 2019 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... Defective Container: Potential for broken glass in the neck area of the glass bottles. Class II Mylan Pharmaceuticals Inc.
Dec 14, 2018 Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Class II Cipla Limited
Oct 3, 2018 Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... Class III InvaGen Pharmaceuticals, Inc.
Sep 6, 2018 Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... Failed impurities/ degradation specifications: Out-of-specification results were observed in the ... Class III InvaGen Pharmaceuticals, Inc.
Jul 25, 2018 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... Presence of foreign substance: Potential for glass in the neck area of the glass bottles. Class II Mylan Pharmaceuticals Inc.
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 5, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... Failed impurities/degradation specifications: Failure to water content and impurity Class III InvaGen Pharmaceuticals, Inc.
Aug 10, 2017 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg p... Presence of Foreign Substance: customer complaint of blue foreign material identified as a portio... Class II Morton Grove Pharmaceuticals, Inc.
Jul 25, 2017 Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... Failed Impurities/Degradation Specifications: high out of specification results for related compo... Class III Teva Pharmaceuticals USA
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's 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.