Browse Drug Recalls
12 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 12 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 12 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 8, 2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syring... | Lack of Assurance of Sterility: | Class II | ASTRAZENECA PHARMACEUTICALS |
| May 14, 2025 | Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inh... | Defective delivery system | Class II | AsttraZeneca Pharmaceuticals LP |
| Mar 15, 2021 | Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budeso... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Feb 23, 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... | Class III | AstraZeneca Pharmaceuticals LP |
| May 25, 2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx... | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bott... | Class I | AstraZeneca Pharmaceuticals, LP |
| Feb 5, 2016 | Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuati... | Defective Delivery System: Some units have actuation counters set to a number other than 60. | Class II | AstraZeneca Pharmaceuticals LP |
| Jun 10, 2015 | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b... | Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an ... | Class II | AstraZeneca Pharmaceuticals LP |
| Jun 21, 2013 | MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, ... | Presence of Precipitate; potential for incomplete constitution upon addition of diluent. | Class II | AstraZeneca Pharmaceuticals LP |
| Jun 5, 2012 | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... | Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... | Class II | Bristol-myers Squibb Company |
| Jun 5, 2012 | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... | Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... | Class II | Bristol-myers Squibb Company |
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.