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Drug recalls

Drug recalls from FDA, newest first.
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2 recalls

Amneal Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

3 recalls

A&P Creations biQ-FEL and X10 Natural Enhancement Supplements

BiQ-FEL contains undeclared Sildenafil and Tadalafil, which may lower blood pressure to dangerous levels.

High risk, FDA, Hidden drug ingredient

Safecor Health Fluphenazine HCl Oral Elixir

Fluphenazine HCl Elixir failed stability specifications.

Moderate risk, FDA, Quality testing problem

New York Blood Center Enterprises Plasma and Red Blood Cells

Liquid Plasma, collected in an expired collection kit, was distributed.

Low risk, FDA

2 recalls

Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections

Centric Compounding injections have been found to be compounded with a Glutathione API containing elevated endotoxin levels.

High risk, FDA, Sterility problem

Taro Lidocaine Ointment

Lidocaine Ointment USP, 5%, Speermint Flavor failed content uniformity specifications and assay specifications.

Moderate risk, FDA, Quality testing problem

1 recall

OurPharma FentaNYL Citrate Injection Solution

FentaNYL Citrate Injection solution has a labeling discrepancy between the IV bag expiry and the product expiry.

Moderate risk, FDA, Labeling error

2 recalls

ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution

The ophthalmic solution is subpotent.

Low risk, FDA, Wrong drug strength

Ajanta Pharma Fluphenazine Hydrochloride Tablets

Fluphenazine Hydrochloride Tablets failed impurity specifications during stability testing.

Low risk, FDA, Drug impurity

3 recalls

American Regent Epinephrine Injection

Presence of Particulate Matter and Lack of Assurance of Sterility.

High risk, FDA, Sterility problem

Trokendi XR (Topiramate) Extended-Release Capsules

Trokendi XR extended-release capsules failed dissolution specifications.

Low risk, FDA, Drug dissolving problem

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for injection fails dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

1 recall

Teva Trazodone Hydrochloride Tablets

TraZODone Hydrochloride Tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

1 recall

Sage Chlorhexidine Gluconate Cloths

The 2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths may cause cross contamination with other products.

Moderate risk, FDA, Contamination

1 recall

American Health Packaging Buprenorphine Sublingual Tablets

Buprenorphine Sublingual Tablets have a labeling mix-up.

Low risk, FDA, Labeling error

5 recalls

GSMS Prasugrel HCI Tablets

Prasugrel tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Mylan Prasugrel Tablets

Prasugrel Tablets, USP, 10mg failed dissolution specifications and stability testing.

Moderate risk, FDA, Drug dissolving problem

The One SPF 50 Invisible Sunscreen Gel

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL may not reliably provide the SPF 50 protection stated on the label.

Moderate risk, FDA, Wrong drug strength

Bionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg

Doxylamine Succinate and Pyridoxine HCl tablets may contain foreign tablets or capsules.

Low risk, FDA, Foreign object

Baxter Vancomycin, Insulin, Daptomycin and Other Injections

Vancomycin Injection, USP in 5% Dextrose has CGMP deviations.

Moderate risk, FDA, Manufacturing problem

2 recalls

B. Braun 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Apotex Paxil CR, Paroxetine, Extended-Release Tablets

Paxil CR tablets failed dissolution specifications and stability testing acceptance criteria.

Moderate risk, FDA, Drug dissolving problem

4 recalls

Exelan Pharmaceuticals Ramipril Capsules USP

Ramipril Capsules USP, 10 mg, failed impurity specifications.

Moderate risk, FDA, Drug impurity

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus

Zicam Cold Remedy Medicated Nasal Swabs have out of limit results for microbiological testing.

Moderate risk, FDA, Manufacturing problem

Acthar Gel (Repository Corticotropin Injection)

Acthar Gel contains particulate matter, glass and stopper piece.

Moderate risk, FDA, Foreign object

Lupin Clobetasol Propionate Cream

Clobetasol Propionate Cream USP, 0.05%, 60 g tube failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

1 recall

Baxter Dextrose Injection

Dextrose Injection contains stainless steel particles that may cause serious health consequences.

High risk, FDA, Foreign object

1 recall

Whitebridge Pet Brands Remedy Recovery Dogswell Pet Wormer

This recall has been initiated out of an abundance of caution, due to complaints related to adverse events after administration of Remedy+ Recovery Dogswell Pet Wormer.

Moderate risk, FDA

2 recalls

Vitruvias Therapeutics Thyroid Tablets

Thyroid Tablets, USP are superpotent and can cause hyperthyroidism.

High risk, FDA, Wrong drug strength

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

4 recalls

B. Braun Lactated Ringer's Injection

Presence of Particulate matter.

High risk, FDA, Foreign object

Optimal Balance Pharmacy Glutathione Injection

Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.

High risk, FDA, Sterility problem

Golden State Medical Supply Carbamazepine Tablets

Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Mylan Acamprosate Calcium, Delayed-Release Tablets

Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

1 recall

Taro Carbamazepine Tablets

Carbamazepine tablets may contain black specks from burnt excipient during manufacturing.

Moderate risk, FDA, Quality problem

2 recalls

Amneal PEMRYDI RTU (Pemetrexed Injection)

PEMRYDI RTU (pemetrexed injection) has a discolored solution, which can be green to dark green.

Moderate risk, FDA, Quality problem

Libtayo (Cemiplimab-Rwlc) Injection

Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls

Shoolin Pharma Chem Sildenafil Citrate and Tadalafil

Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.

Moderate risk, FDA, Manufacturing problem

CLEAR EYES Maximum Itchy Eye Relief

CLEAR EYES Maximum Itchy Eye Relief lacks assurance of sterility and may be contaminated.

Moderate risk, FDA, Sterility problem

2 recalls

Tyenne (Tocilizumab-Aazg) Injection

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, swelling, vein inflammation, blood clots, and organ damage.

High risk, FDA, Foreign object

Avet Pharmaceuticals Clindamycin Palmitate Hydrochloride for Oral Solution

Clindamycin palmitate hydrochloride oral solution contains particles and white flakes in reconstituted bottles.

Moderate risk, FDA, Foreign object

2 recalls

Novartis Diovan Tablets

Diovan (valsartan) 160 mg tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Apollo Care Semaglutide Injection Vials

Semaglutide sterile multi-dose vials contain particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.

Moderate risk, FDA, Foreign object

1 recall

Zydus Mirabegron Extended-Release Tablets

Mirabegron Extended-Release Tablets contain an impurity above specification.

Moderate risk, FDA, Drug impurity

1 recall

Victory Medical Center Pharmacy Glutathione Injection

Compounded glutathione vials have elevated bacterial endotoxin levels, which could cause fever, hypotension, inflammatory reactions, anaphylactic shock.

High risk, FDA, Sterility problem

2 recalls

Fresenius Kabi Morphine Sulfate Injection

Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

High risk, FDA, Labeling error

Aurobindo Pharma Dicyclomine Hydrochloride Capsules

Dicyclomine Hydrochloride Capsules are shortfilled, with reports of empty capsules.

Moderate risk, FDA, Quality problem

3 recalls

Adequan Canine and Equine Injections

Adequan Canine and Adequan i.m. injections contain glass fibers that may cause irritation, swelling, or infection.

Moderate risk, FDA, Contamination

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

Optiray Imaging Bulk Package-350 contains particulate matter including plastic and glass, which may cause local irritation or swelling.

High risk, FDA, Foreign object

Parnell Sevoflurane Inhalation Anesthetic for Dogs

Sevoflurane inhalation solution has a bottle collar notch pattern incompatible with the sevoflurane-specific anti-spill pour spout.

FDA