Disclaimer: Recall Radar is an informational summary of public FDA enforcement reports. It is not medical advice. Always confirm details with the FDA, the company, a pharmacist, or a doctor before making health decisions.
Drug Recalls
Recent FDA drug recalls of prescription and over-the-counter medicines, from openFDA enforcement reports. Never stop a prescribed medication without talking to your pharmacist or doctor first.
135 recalls from FDA enforcement reports in the last ~60 days. Updated 2026-10-13.
Benzoyl Peroxide Wash
SV Labs Toronto Corporation · October 7, 2026
Microbial contamination of topical product.
Estradiol Gel
Amneal Pharmaceuticals, LLC · October 7, 2026
Defective Container; packets were found to be either empty or partially full.
Focus PI Hypromellose 0.7% Formula
Aurolab Trust · October 7, 2026
Lack of Assurance of Sterility
Zoladex
TerSera Therapeutics LLC · October 7, 2026
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
amazon
Aurobindo Pharma USA Inc · October 7, 2026
Discoloration: consumer complaints received for discolored tablets
Paroxetine Extended-Release Tablets
Apotex Corp. · October 7, 2026
Failed dissolution specifications.
Benzoyl Peroxide Wash
SV Labs Toronto Corporation · October 7, 2026
Microbial contamination of topical product.
Ranolazine Extended-Release Tablets
Ajanta Pharma USA Inc · October 7, 2026
Failed Dissolution Specifications: below specification
TRP The Relief Products* Gentle Eyes Lubricant Eye…
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
AvKare Carboxymethylcellulose Sodium Ophthalmic…
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Clear Eyes Redness Relief
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · September 30, 2026
Lack of Assurance of Sterility
AvKare Carboxymethylcellulose Sodium Ophthalmic…
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Lubricant Eye Drops-Cameron Pharmaceuticals
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Reliable -1 Laboratories
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Walgreens Lubricant Eye Drops
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Exenatide Injection
Amneal Pharmaceuticals of New York, LLC · September 30, 2026
Defective Delivery System: Possibility of no medication in the prefilled pen.
Olanzapine Tablets
Macleods Pharmaceuticals Limited · September 30, 2026
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Major LubriFresh P.M
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Walgreens Lubricant Eye Drops
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Clear Eyes Redness Relief
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · September 30, 2026
Lack of Assurance of Sterility
Reliable-1 Laboratories Lubricating Tears
Sterling Pharmaceutical Services LLC · September 30, 2026
Lack of Assurance of Sterility
Menow Sunscreen Pressed Powder Spf35 Pa+++
SHANTOU Qiwei industrial Co., Ltd · September 30, 2026
cGMP Deviations
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Fluphenazine HCl Elixir
Safecor Health, LLC · September 23, 2026
Failed Stability Specifications
Lidocaine Ointment USP
SUN PHARMA /TARO · September 23, 2026
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Chlorthalidone Tablets
Inventia Healthcare Limited · September 23, 2026
Failed Dissolution Specifications
Nystatin Cream
SUN PHARMACEUTICAL INDUSTRIES INC · September 23, 2026
Failed Stability Specifications
fentaNYL Citrate
OurPharma LLC · September 16, 2026
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product …
Povidone Iodine 1.25% / Proparacaine HCl 0.5%…
ImprimisRx NJ LLC · September 16, 2026
Subpotent Drug
Epinephrine Injection
American Regent, Inc. · September 16, 2026
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broke…
Fluphenazine Hydrochloride Tablets
Ajanta Pharma USA Inc · September 16, 2026
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1…
Dextrose Injection
Baxter Healthcare Corporation · September 16, 2026
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
0.9% Sodium Chloride Injection
B BRAUN MEDICAL INC · September 16, 2026
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Clindamycin Injection USP in 5% Dextrose
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
Glutathione 200 mg/mL
OPTIMAL BALANCE PHARMACY · September 9, 2026
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Trokendi XR
Supernus Pharmaceuticals, Inc. · September 9, 2026
Failed dissolution specifications.
Buprenorphine Sublingual Tablets
American Health Packaging · September 9, 2026
Labeling: Label Mix-up
traZODone Hydrochloride Tablets
Teva Pharmaceuticals USA, Inc · September 9, 2026
Presence of Foreign Tablets/Capsules
0.9% Sodium Chloride Injection USP 500 mL
Baxter Healthcare Corporation · September 9, 2026
Presence of particulate matter: Particulates identified as fiberglass
The One Spf 50 Invisible Sunscreen Gel
Allies Group Inc. · September 9, 2026
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
The One Spf 50 Invisible Sunscreen Gel
Allies Group Inc. · September 9, 2026
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
Broadway Joe's Pain Cream
Lexia LLC · September 9, 2026
CGMP Deviations: Potential contamination of raw material
Clindamycin Injection USP in 5% Dextrose
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
The One Spf 50 Invisible Sunscreen Gel
Allies Group Inc. · September 9, 2026
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride…
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
The One Spf 50 Invisible Sunscreen Gel
Allies Group Inc. · September 9, 2026
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Clindamycin Injection USP in 5% Dextrose
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
Broadway Joe's Pain Cream
Lexia LLC · September 9, 2026
CGMP Deviations: Potential contamination of raw material
Doxylamine Succinate and Pyridoxine HCl Delayed-Release…
Bionpharma Inc. · September 9, 2026
Presence of Foreign Tablets/Capsules
Famotidine Injection in Sodium Chloride Injection
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
2% Chlorhexidine Gluconate* Cloth
Sage Products, LLC · September 9, 2026
Cross Contamination with Other Products
Revcovi
Chiesi USA, Inc. · September 9, 2026
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Prasugrel Tablets
Mylan Pharmaceuticals Inc · September 9, 2026
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Clindamycin Injection USP in 5% Dextrose
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
Baxter Healthcare Corporation · September 9, 2026
CGMP Deviations
Carton label
Mylan Pharmaceuticals Inc · September 9, 2026
Failed Dissolution Specifications
Prasugrel HCI
Golden State Medical Supply Inc. · September 9, 2026
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Ramipril Capsules USP
Hikma Pharmaceuticals USA INC. · September 2, 2026
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Clobetasol Propionate Cream USP
Lupin Pharmaceuticals Inc. · September 2, 2026
Failed content uniformity specifications.
Acthar Gel
Mallinckrodt Hospital Products Inc. · September 2, 2026
Presence of particulate matter: glass and stopper piece
Zicam
Church & Dwight Co., Inc. · September 2, 2026
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Tyenne
Fresenius Kabi USA, LLC · September 2, 2026
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Lactated Ringer's Injection USP
B BRAUN MEDICAL INC · September 2, 2026
Presence of Particulate matter.
Paxil CR
Apotex Corp. · September 2, 2026
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Cyanocobalamin injection USP
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Carbamazepine Tablets
Golden State Medical Supply Inc. · August 26, 2026
CGMP deviations: tablets with black specks.
Multrys
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Acetylcysteine Solution
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Papaverine HCl Injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Acetylcysteine Solution
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Pemrydi Rtu
Shilpa Medicare Limited · August 26, 2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Atropine Sulfate injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Nitroglycerin injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Acamprosate Calcium
Mylan Pharmaceuticals Inc · August 26, 2026
Failed Dissolution Specifications
Pemrydi RTU(pemetrexed injection)
Shilpa Medicare Limited · August 26, 2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
niCARdipine Hydrochloride Injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aminaocaproic Acid Injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Selenious Acid Injection
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Morphine Sulfate Injection
Fresenius Kabi USA, LLC · August 26, 2026
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Carbamazepine Tablets
SUN PHARMACEUTICAL INDUSTRIES INC · August 26, 2026
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Cyanocobalamin injection USP
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Tralement
American Regent, Inc. · August 26, 2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Kian Pee Wan Capsules
Buy-Herbal · August 19, 2026
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Sildenafil Citrate USP
Shoolin Pharma Chem LLP · August 19, 2026
CGMP Deviations:Noted during FDA inspection
Semaglutide 7.5mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Glutathione
Victory Medical Center Pharmacy · August 19, 2026
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Semaglutide 12.5mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Semaglutide 2.25mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Optiray Imaging Bulk Package-350
Liebel-Flarsheim Company LLC · August 19, 2026
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Clindamycin Palmitate Hydrochloride for Oral Solution
Heritage Pharmaceuticals Inc · August 19, 2026
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Semaglutide 2.5mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Semaglutide 6.75mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Semaglutide 0.9mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Clear Eyes Maximum Itchy Eye Relief
Prestige Brands Holdings · August 19, 2026
Lack of assurance of sterility. The recall is due to potential contamination
Semaglutide 20mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Semaglutide 10mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Semaglutide 9mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Tadalafil USP
Shoolin Pharma Chem LLP · August 19, 2026
CGMP Deviations:Noted during FDA inspection
Tadalafil USP
Shoolin Pharma Chem LLP · August 19, 2026
CGMP Deviations:Noted during FDA inspection
Semaglutide 4.5mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Diovan
Novartis Pharmaceuticals Corporation · August 19, 2026
Failed Dissolution Specifications
Semaglutide 5mg
Apollo Care, LLC · August 19, 2026
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Cefazolin in Dextrose
Baxter Healthcare Corporation · August 19, 2026
Presence of Particulate Matter
Sildenafil Citrate USP
Shoolin Pharma Chem LLP · August 19, 2026
CGMP Deviations:Noted during FDA inspection
Tadalafil USP
Shoolin Pharma Chem LLP · August 19, 2026
CGMP Deviations:Noted during FDA inspection
Guides for drug recalls
Frequently asked questions
What is a Class I recall?
Class I is the FDA's most serious recall classification. It means there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. Class II recalls involve products that may cause temporary or medically reversible problems, and Class III recalls involve products unlikely to cause harm that still violate FDA rules.
How do I find the lot number on my product?
Lot numbers, batch codes and dates are usually printed or stamped on the package: on the bottom of cans and jars, on the side or top of boxes and cartons, near the best-by date on bags and pouches, or on the label of bottles and vials. Each recall page lists the exact codes from the FDA report so you can compare them.
What should I do if I already ate or used a recalled product?
Don't panic: many people who use a recalled product never get sick. Stop using it, and watch for symptoms related to the hazard described on the recall page. If you have symptoms, are pregnant, have a weakened immune system, or are worried, contact a doctor or pharmacist. In an emergency, call 911. Don't stop a prescribed medication without talking to your pharmacist or doctor first.
Can I get a refund for a recalled product?
Usually, yes. Recalling companies typically offer refunds or replacements, and many stores accept returns of recalled items. Check the company's recall notice or ask the store where you bought it.
Where does this information come from?
Recall Radar summarizes public FDA enforcement reports from the openFDA API and updates daily. Always confirm details with the FDA, the company, or a health professional.
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