About Medication Recalls
Medication recalls are issued when a prescription or over-the-counter drug is found to be defective, contaminated, or otherwise unsafe. The FDA's Center for Drug Evaluation and Research (CDER) oversees drug recalls in the United States and maintains the enforcement action database that powers this page.
Common causes of drug recalls include microbial or chemical contamination during manufacturing, incorrect potency (meaning a dose contains more or less of the active ingredient than labeled), labeling errors that could lead to medication errors, the presence of foreign particles or sub-potent ingredients, and products that fail sterility testing. In some cases, recalls occur because a facility failed to meet Good Manufacturing Practice (GMP) standards, even if no specific product defect has been identified yet.
Drug recalls are classified the same way as food recalls. A Class I recall means there is a reasonable probability that using the product will cause or lead to serious adverse health consequences or death — for example, a blood pressure medication with no active ingredient, or an injectable drug contaminated with bacteria. A Class II recall covers products that may cause temporary, reversible health effects. A Class III recall involves products that are unlikely to cause harm but violate FDA regulations.
If you take a recalled medication, do not stop taking a prescription without speaking to your doctor or pharmacist first — abruptly discontinuing some medications can be dangerous. Bring the recalled product to your pharmacy; they can check lot numbers and arrange a replacement. Never flush medication down the toilet unless the recall notice specifically instructs you to. Use the FDA's drug take-back program or an approved disposal method.
Important: Always consult your doctor or pharmacist before stopping or switching any prescription medication, even if it has been recalled. Your health provider can advise on the safest course of action.
NoticeMedications
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bott
Hikma Pharmaceuticals USA INC.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
NoticeMedications
Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcoho
Safecor Health, LLC
Cross Contamination with Other Products
NoticeMedications
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,
Apotex Corp.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
⚠ Active RecallMedications
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35
B BRAUN MEDICAL INC
Presence of Particulate matter.
NoticeMedications
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free
Church & Dwight Co., Inc.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
⚠ Active RecallMedications
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,
Fresenius Kabi USA, LLC
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
NoticeMedications
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-
Golden State Medical Supply Inc.
CGMP deviations: tablets with black specks.
NoticeMedications
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-cou
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, I
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridg
Mallinckrodt Hospital Products Inc.
Presence of particulate matter: glass and stopper piece
NoticeMedications
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-c
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-coun
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
ACCORD HEALTHCARE, INC.
Subpotent Drug
NoticeMedications
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,
Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
⚠ Active RecallMedications
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenou
Fresenius Kabi USA, LLC
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
NoticeMedications
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 2783
Novartis Pharmaceuticals Corporation
Failed Dissolution Specifications
NoticeMedications
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LL
Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
NoticeMedications
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34
Lupin Pharmaceuticals Inc.
Failed content uniformity specifications.
NoticeMedications
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block
Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
NoticeMedications
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Ha
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
NoticeMedications
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Blo
Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
NoticeMedications
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LL
Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
NoticeMedications
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/S
Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
⚠ Active RecallMedications
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,
Liebel-Flarsheim Company LLC
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
NoticeMedications
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceut
Heritage Pharmaceuticals Inc
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
NoticeMedications
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifescie
Shilpa Medicare Limited
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
NoticeMedications
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarr
Prestige Brands Holdings
Lack of assurance of sterility. The recall is due to potential contamination
NoticeMedications
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifescienc
Shilpa Medicare Limited
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
NoticeMedications
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 M
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only
Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
NoticeMedications
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial,
Regeneron Pharmaceuticals Inc
Lack of Assurance of Sterility
NoticeMedications
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vi
American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
NoticeMedications
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302
American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
NoticeMedications
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x
American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde