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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.