FDA Enforcement Report
Drug recalls
In the last two years the FDA's Enforcement Report lists 842 drug recall entries by their listed makers naming 289 medicines on this site. Find a medicine to see every recall that names it, with its class and reason.
Which medicines were recalled most in two years?
Counted by recalls of firms listed as the medicine's makers or holding its application; a recall by any other firm (a compounding pharmacy, a bulk supplier) is on the medicine's record, not in this count.
| Medicine | Recall entries | Class I | Latest |
|---|---|---|---|
| Levothyroxine | 62 | 0 | August 6, 2026 |
| Duloxetine | 40 | 0 | June 4, 2026 |
| Cinacalcet | 27 | 0 | June 29, 2026 |
| Chlorpromazine | 25 | 0 | September 3, 2025 |
| Sodium chloride | 23 | 3 | September 11, 2026 |
| Testosterone | 20 | 0 | January 26, 2026 |
| Chlorhexidine and isopropyl alcohol | 17 | 3 | July 9, 2026 |
| Atomoxetine | 15 | 0 | April 30, 2026 |
| Carvedilol | 14 | 0 | August 20, 2025 |
| Clindamycin | 11 | 0 | August 6, 2026 |
| Estradiol | 11 | 0 | May 12, 2026 |
| Lidocaine | 10 | 0 | August 31, 2026 |
| Lisdexamfetamine | 10 | 0 | October 28, 2025 |
| Fluphenazine | 9 | 0 | August 25, 2026 |
| Prazosin | 9 | 0 | March 27, 2026 |
| Haloperidol | 8 | 0 | October 10, 2025 |
| Metoprolol | 8 | 0 | April 27, 2026 |
| Amphetamine and dextroamphetamine | 7 | 0 | June 26, 2026 |
| Dabigatran | 7 | 0 | July 16, 2026 |
| Diltiazem | 7 | 0 | March 13, 2025 |
| Gabapentin | 7 | 0 | October 10, 2025 |
| Desipramine | 6 | 0 | October 6, 2025 |
| Lacosamide | 6 | 0 | June 4, 2026 |
| Morphine | 6 | 1 | August 4, 2026 |
| Pitavastatin | 6 | 0 | February 3, 2026 |
| Primidone | 6 | 0 | June 3, 2026 |
| Atorvastatin | 5 | 0 | September 19, 2025 |
| Clomipramine | 5 | 0 | October 22, 2025 |
| Dextrose | 5 | 1 | August 17, 2026 |
| Everolimus | 5 | 0 | October 10, 2025 |
| Fentanyl | 5 | 1 | September 3, 2026 |
| Potassium chloride | 5 | 4 | October 29, 2025 |
| Sulfamethoxazole and trimethoprim | 5 | 1 | September 2, 2025 |
| Timolol | 5 | 0 | July 5, 2025 |
| Vancomycin | 5 | 0 | August 6, 2026 |
| Calcium chloride, potassium chloride, sodium chloride and sodium lactate | 4 | 3 | August 12, 2026 |
| Cetirizine | 4 | 1 | June 24, 2026 |
| Clonazepam | 4 | 4 | November 18, 2024 |
| Entecavir | 4 | 0 | September 24, 2025 |
| Glycopyrrolate | 4 | 0 | July 16, 2026 |
| Isotretinoin | 4 | 0 | April 6, 2026 |
| Ketamine | 4 | 0 | April 1, 2026 |
| Lanthanum | 4 | 0 | October 24, 2025 |
| Mepivacaine | 4 | 0 | October 31, 2025 |
| Niacin | 4 | 0 | May 29, 2026 |
| Nicardipine | 4 | 0 | August 6, 2026 |
| Octreotide | 4 | 0 | April 24, 2026 |
| Pemetrexed | 4 | 0 | July 29, 2026 |
| Prasugrel | 4 | 0 | August 21, 2026 |
| Pravastatin | 4 | 0 | March 13, 2025 |
| Propafenone | 4 | 0 | March 13, 2025 |
| Ramipril | 4 | 0 | August 24, 2026 |
| Amlodipine and olmesartan | 3 | 0 | July 8, 2026 |
| Brimonidine and timolol | 3 | 0 | March 5, 2026 |
| Buprenorphine | 3 | 0 | August 19, 2026 |
| Carbamazepine | 3 | 0 | August 7, 2026 |
| Chlorthalidone | 3 | 0 | September 3, 2026 |
| Cisatracurium | 3 | 0 | November 26, 2025 |
| Clonidine | 3 | 0 | March 19, 2026 |
| Cyclophosphamide | 3 | 2 | July 17, 2026 |
Source: FDA Enforcement Report (drug recalls) via openFDA
The newest recalls
| Started | Medicine | Class | Company | Reason |
|---|---|---|---|---|
| September 14, 2026 | Nystatin | Not Yet Classified | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Stability Specifications |
| September 11, 2026 | Sodium chloride | Not Yet Classified | Otsuka ICU Medical LLC | Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM … |
| September 4, 2026 | Dopamine | Class II | Pfizer | Lack of Assurance of Sterility |
| September 3, 2026 | Chlorthalidone | Class II | Inventia Healthcare Limited | Failed Dissolution Specifications |
| September 3, 2026 | Fentanyl | Class II | OurPharma LLC | Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and … |
| August 31, 2026 | Topiramate | Class III | Supernus Pharmaceuticals, Inc. | Failed dissolution specifications. |
| August 31, 2026 | Lidocaine | Class II | SUN PHARMA /TARO | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at … |
| August 28, 2026 | Exenatide | Class II | Amneal Pharmaceuticals of New York, LLC | Defective Delivery System: Possibility of no medication in the prefilled pen. |
| August 27, 2026 | Olanzapine | Class III | Macleods Pharmaceuticals Limited | Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. |
| August 26, 2026 | Mycophenolate mofetil | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications |
| August 25, 2026 | Fluphenazine | Class III | Ajanta Pharma USA Inc | Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term … |
| August 24, 2026 | Ramipril | Class II | Hikma Pharmaceuticals USA INC. | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). |
| August 24, 2026 | Trazodone | Class II | Teva Pharmaceuticals USA, Inc | Presence of Foreign Tablets/Capsules |
| August 21, 2026 | Prasugrel | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution |
| August 21, 2026 | Thyroid | Class I | VITRUVIAS THERAPEUTICS INC | Superpotent Drug |
| August 20, 2026 | Carboxymethylcellulose | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 20, 2026 | Sodium chloride | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 20, 2026 | Carboxymethylcellulose | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 20, 2026 | Carboxymethylcellulose | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 20, 2026 | Carboxymethylcellulose | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 20, 2026 | Carboxymethylcellulose | Class II | Sterling Pharmaceutical Services LLC | Lack of Assurance of Sterility |
| August 19, 2026 | Elapegademase | Class III | Chiesi USA, Inc. | Failed Stability Specifications: Out of specification stability result for the protein concentration profile. |
| August 19, 2026 | Buprenorphine | Class III | American Health Packaging | Labeling: Label Mix-up |
| August 19, 2026 | Sodium chloride | Class I | B BRAUN MEDICAL INC | Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene |
| August 18, 2026 | Chlorhexidine | Class II | Sage Products, LLC | Cross Contamination with Other Products |
| August 17, 2026 | Prasugrel | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria |
| August 17, 2026 | Sodium chloride | Class I | Baxter Healthcare Corporation | Presence of particulate matter: Particulates identified as fiberglass |
| August 17, 2026 | Dextrose | Class I | Baxter Healthcare Corporation | Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. |
| August 13, 2026 | Paroxetine | Class II | Apotex Corp. | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria |
| August 13, 2026 | Fluphenazine | Class II | Safecor Health, LLC | Failed Stability Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA
What next?
- Why medicines are recalled
- reasons since 2024
- FDA recalls explained
- classes and what they mean