Recall Radar

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.

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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.

Class IIDrug

Benzoyl Peroxide Wash

SV Labs Toronto Corporation · October 7, 2026

Microbial contamination of topical product.

Class IIDrug

Estradiol Gel

Amneal Pharmaceuticals, LLC · October 7, 2026

Defective Container; packets were found to be either empty or partially full.

Class IIDrug

Focus PI Hypromellose 0.7% Formula

Aurolab Trust · October 7, 2026

Lack of Assurance of Sterility

Class IIDrug

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.

Not Yet ClassifiedDrug

amazon

Aurobindo Pharma USA Inc · October 7, 2026

Discoloration: consumer complaints received for discolored tablets

Class IIDrug

Paroxetine Extended-Release Tablets

Apotex Corp. · October 7, 2026

Failed dissolution specifications.

Class IIDrug

Benzoyl Peroxide Wash

SV Labs Toronto Corporation · October 7, 2026

Microbial contamination of topical product.

Class IIDrug

Buprenorphine Hydrochloride

Par Health USA, LLC · October 7, 2026

Crystallization

Class IIDrug

Ranolazine Extended-Release Tablets

Ajanta Pharma USA Inc · October 7, 2026

Failed Dissolution Specifications: below specification

Class IIDrug

TRP The Relief Products* Gentle Eyes Lubricant Eye…

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

AvKare Carboxymethylcellulose Sodium Ophthalmic…

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Clear Eyes Redness Relief

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

AvKare Carboxymethylcellulose Sodium Ophthalmic…

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Lubricant Eye Drops-Cameron Pharmaceuticals

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Reliable -1 Laboratories

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Walgreens Lubricant Eye Drops

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Exenatide Injection

Amneal Pharmaceuticals of New York, LLC · September 30, 2026

Defective Delivery System: Possibility of no medication in the prefilled pen.

Class IIIDrug

Olanzapine Tablets

Macleods Pharmaceuticals Limited · September 30, 2026

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Class IIDrug

Major LubriFresh P.M

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Walgreens Lubricant Eye Drops

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Clear Eyes Redness Relief

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Reliable-1 Laboratories Lubricating Tears

Sterling Pharmaceutical Services LLC · September 30, 2026

Lack of Assurance of Sterility

Class IIDrug

Menow Sunscreen Pressed Powder Spf35 Pa+++

SHANTOU Qiwei industrial Co., Ltd · September 30, 2026

cGMP Deviations

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IDrug

Thyroid Tablets

VITRUVIAS THERAPEUTICS INC · September 23, 2026

Superpotent Drug

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IIDrug

Fluphenazine HCl Elixir

Safecor Health, LLC · September 23, 2026

Failed Stability Specifications

Class IIDrug

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).

Class IIDrug

Chlorthalidone Tablets

Inventia Healthcare Limited · September 23, 2026

Failed Dissolution Specifications

Not Yet ClassifiedDrug

Nystatin Cream

SUN PHARMACEUTICAL INDUSTRIES INC · September 23, 2026

Failed Stability Specifications

Class IIDrug

Dopamine HCl Inj.

Pfizer · September 23, 2026

Lack of Assurance of Sterility

Class IIDrug

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 …

Class IIIDrug

Povidone Iodine 1.25% / Proparacaine HCl 0.5%…

ImprimisRx NJ LLC · September 16, 2026

Subpotent Drug

Class IDrug

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…

Class IIIDrug

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…

Class IDrug

Dextrose Injection

Baxter Healthcare Corporation · September 16, 2026

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Class IDrug

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

Class IIDrug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Vasopressin

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Daptomycin

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IDrug

Glutathione 200 mg/mL

OPTIMAL BALANCE PHARMACY · September 9, 2026

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Class IIDrug

Cardene IV

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIIDrug

Trokendi XR

Supernus Pharmaceuticals, Inc. · September 9, 2026

Failed dissolution specifications.

Class IIIDrug

Buprenorphine Sublingual Tablets

American Health Packaging · September 9, 2026

Labeling: Label Mix-up

Class IIDrug

traZODone Hydrochloride Tablets

Teva Pharmaceuticals USA, Inc · September 9, 2026

Presence of Foreign Tablets/Capsules

Class IDrug

0.9% Sodium Chloride Injection USP 500 mL

Baxter Healthcare Corporation · September 9, 2026

Presence of particulate matter: Particulates identified as fiberglass

Class IIDrug

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.

Class IIDrug

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.

Class IIDrug

Pantoprazole Sodium in 0.9% Sodium Chloride Injection

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Broadway Joe's Pain Cream

Lexia LLC · September 9, 2026

CGMP Deviations: Potential contamination of raw material

Class IIDrug

Daptomycin

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Nexterone

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

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.

Class IIDrug

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride…

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

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.

Class IIDrug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Broadway Joe's Pain Cream

Lexia LLC · September 9, 2026

CGMP Deviations: Potential contamination of raw material

Class IIDrug

Myxredlin

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIIDrug

Doxylamine Succinate and Pyridoxine HCl Delayed-Release…

Bionpharma Inc. · September 9, 2026

Presence of Foreign Tablets/Capsules

Class IIDrug

Famotidine Injection in Sodium Chloride Injection

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Vancomycin Injection

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Vasopressin

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

2% Chlorhexidine Gluconate* Cloth

Sage Products, LLC · September 9, 2026

Cross Contamination with Other Products

Class IIIDrug

Revcovi

Chiesi USA, Inc. · September 9, 2026

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Class IIDrug

Prasugrel Tablets

Mylan Pharmaceuticals Inc · September 9, 2026

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Class IIDrug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Vancomycin Injection

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Clindamycin Phosphate in 0.9% Sodium Chloride Injection

Baxter Healthcare Corporation · September 9, 2026

CGMP Deviations

Class IIDrug

Carton label

Mylan Pharmaceuticals Inc · September 9, 2026

Failed Dissolution Specifications

Class IIDrug

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

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Ramipril Capsules USP

Hikma Pharmaceuticals USA INC. · September 2, 2026

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Clobetasol Propionate Cream USP

Lupin Pharmaceuticals Inc. · September 2, 2026

Failed content uniformity specifications.

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Acthar Gel

Mallinckrodt Hospital Products Inc. · September 2, 2026

Presence of particulate matter: glass and stopper piece

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Zicam

Church & Dwight Co., Inc. · September 2, 2026

CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IDrug

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.

Class IDrug

Lactated Ringer's Injection USP

B BRAUN MEDICAL INC · September 2, 2026

Presence of Particulate matter.

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC. · September 2, 2026

Subpotent Drug

Class IIDrug

Paxil CR

Apotex Corp. · September 2, 2026

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Class IIDrug

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

Class IIDrug

Carbamazepine Tablets

Golden State Medical Supply Inc. · August 26, 2026

CGMP deviations: tablets with black specks.

Class IIDrug

Multrys

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class IIDrug

Acetylcysteine Solution

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class IDrug

Papaverine HCl Injection

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Class IIDrug

Acetylcysteine Solution

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class IIDrug

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

Class IIDrug

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

Class IIDrug

Libtayo

Regeneron Pharmaceuticals Inc · August 26, 2026

Lack of Assurance of Sterility

Class IIDrug

Nitroglycerin injection

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class IIDrug

Acamprosate Calcium

Mylan Pharmaceuticals Inc · August 26, 2026

Failed Dissolution Specifications

Class IIDrug

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

Class IIDrug

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

Class IIDrug

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

Class IIDrug

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

Class IDrug

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.

Class IIDrug

Carbamazepine Tablets

SUN PHARMACEUTICAL INDUSTRIES INC · August 26, 2026

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Class IIDrug

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

Class IIDrug

Tralement

American Regent, Inc. · August 26, 2026

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class IDrug

Kian Pee Wan Capsules

Buy-Herbal · August 19, 2026

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Class IIDrug

Sildenafil Citrate USP

Shoolin Pharma Chem LLP · August 19, 2026

CGMP Deviations:Noted during FDA inspection

Class IIDrug

Semaglutide 7.5mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IDrug

Glutathione

Victory Medical Center Pharmacy · August 19, 2026

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Class IIDrug

Semaglutide 12.5mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Semaglutide 2.25mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IDrug

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.

Class IIDrug

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.

Class IIDrug

Semaglutide 2.5mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Semaglutide 6.75mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Semaglutide 0.9mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Clear Eyes Maximum Itchy Eye Relief

Prestige Brands Holdings · August 19, 2026

Lack of assurance of sterility. The recall is due to potential contamination

Class IIDrug

Semaglutide 20mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Semaglutide 10mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Semaglutide 9mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Tadalafil USP

Shoolin Pharma Chem LLP · August 19, 2026

CGMP Deviations:Noted during FDA inspection

Class IIDrug

Tadalafil USP

Shoolin Pharma Chem LLP · August 19, 2026

CGMP Deviations:Noted during FDA inspection

Class IIDrug

Semaglutide 4.5mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IIDrug

Diovan

Novartis Pharmaceuticals Corporation · August 19, 2026

Failed Dissolution Specifications

Class IIDrug

Semaglutide 5mg

Apollo Care, LLC · August 19, 2026

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class IDrug

Cefazolin in Dextrose

Baxter Healthcare Corporation · August 19, 2026

Presence of Particulate Matter

Class IIDrug

Sildenafil Citrate USP

Shoolin Pharma Chem LLP · August 19, 2026

CGMP Deviations:Noted during FDA inspection

Class IIDrug

Tadalafil USP

Shoolin Pharma Chem LLP · August 19, 2026

CGMP Deviations:Noted during FDA inspection

Guides for drug recalls

All guides

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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