Browse Drug Recalls
522 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 522 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 522 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2026 | Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for:... | Failed content uniformity specifications. | Class II | Lupin Pharmaceuticals Inc. |
| Aug 3, 2026 | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compoundi... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compo... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compoun... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescriptio... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Jul 31, 2026 | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organical... | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless st... | Class I | Liebel-Flarsheim Company LLC |
| Jul 30, 2026 | CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx On... | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. | Class II | Heritage Pharmaceuticals Inc |
| Jul 29, 2026 | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial,... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| Jul 29, 2026 | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose via... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| Jul 29, 2026 | SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Via... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcu... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vi... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vi... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, St... | Lack of assurance of sterility. The recall is due to potential contamination | Class II | Prestige Brands Holdings |
| Jul 29, 2026 | SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For ... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Do... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For ... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dos... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 28, 2026 | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous ... | Lack of Assurance of Sterility | Class II | Regeneron Pharmaceuticals Inc |
| Jul 24, 2026 | Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose ... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Inf... | Presence of Particulate Matter | Class I | Baxter Healthcare Corporation |
| Jul 24, 2026 | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged i... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, p... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 m... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc |
| Jul 24, 2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL via... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packa... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Sing... | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass ... | Class I | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC U... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 23, 2026 | Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distri... | shortfill; reports of empty capsules. | Class II | Aurobindo Pharma USA Inc |
| Jul 23, 2026 | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 22, 2026 | Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL -... | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. | Class II | MICRO LABS USA INC |
| Jul 17, 2026 | Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx on... | Presence of Particulate Matter; identified as stainless steel | Class I | Sunny Pharmtech Inc. |
| Jul 17, 2026 | Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx on... | Presence of Particulate Matter; identified as stainless steel | Class I | Sunny Pharmtech Inc. |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further p... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient sp... | Incorrect Product Formulation | Class III | Central Admixture Pharmacy Services Inc |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further pa... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further pac... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill... | Presence of Particulate Matter: Hair was found in product | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single D... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
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.