Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2024 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit co... | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product | Class II | Curium US, LLC |
| Nov 6, 2024 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syr... | Lack of Sterility Assurance | Class II | Tailstorm Health INC |
| Sep 16, 2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 16, 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 5, 2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... | Lack of Assurance of Sterility | Class II | Empower Pharmacy |
| Aug 22, 2024 | SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 15, 2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx o... | Lack of Assurance of Sterility | Class II | Fagron Compounding Services |
| Aug 2, 2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... | Lack of Assurance of Sterility | Class II | EMPOWER CLINIC SERVICES LLC |
| Jun 17, 2024 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... | Class II | Baxter Healthcare Corporation |
| May 23, 2024 | Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... | Lack of Assurance of Sterility: Leaking vials | Class II | Dr. Reddy's Laboratories, Inc. |
| May 20, 2024 | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Class II | Pfizer Inc. |
| May 20, 2024 | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Class II | Pfizer Inc. |
| May 20, 2024 | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F... | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ... | Class II | Genentech, Inc. |
| May 15, 2024 | EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a... | Lack of Assurance of Sterility: Complaints of syringe breakage | Class II | Regeneron Pharmaceuticals Inc |
| May 14, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... | Lack of Assurance of Sterility. | Class II | American Regent, Inc. |
| May 14, 2024 | Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intra... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraoc... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Pres... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| May 14, 2024 | Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ... | Lack of Assurance of Sterility | Class II | Imprimis NJOF, LLC |
| Apr 23, 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... | Lack of Assurance of Sterility: Complaints of syringe breakage | Class II | Regeneron Pharmaceuticals Inc |
| Mar 22, 2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... | Lack of assurance of sterility: bags have the potential to leak.. | Class II | B. Braun Medical Inc |
| Mar 22, 2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... | Lack of Assurance of Sterility: leaking bags | Class II | IntegraDose Compounding Services LLC |
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Mar 5, 2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Class II | Thea Pharma, Inc. |
| Feb 29, 2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manuf... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Feb 29, 2024 | TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Ma... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Jan 30, 2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
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.