Skip to main content

FDA drug recalls

Drug recalls from FDA, newest first. 358 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Filters · 1Sort Newest
Agency
Risk level
Status
Date
Sold in

2 recalls that day

Apotex Paxil CR, Paroxetine, Extended-Release Tablets

Paxil CR, Paroxetine, Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

4 recalls that day

Exelan Pharmaceuticals Ramipril Capsules USP

Ramipril Capsules USP, 10 mg may contain more impurities than allowed.

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 failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

3 recalls that day

Baxter Dextrose Injection

Dextrose Injection, USP, 70 % may contain stainless steel particles, which can cause serious health problems.

High risk, FDA, Foreign object

Baxter 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains fiberglass particulate matter that may cause serious health consequences.

High risk, FDA, Foreign object

Safecor Health Ibuprofen Oral Suspension

Ibuprofen oral suspension may be cross-contaminated with other products.

High risk, FDA, Contamination

1 recall that day

Whitebridge Pet Brands Remedy Recovery Dogswell Pet Wormer

The product may cause adverse events in pets.

Moderate risk, FDA

2 recalls that day

Vitruvias Therapeutics Thyroid Tablets

Vitruvias Therapeutics Thyroid Tablets, USP may be stronger than labeled.

High risk, FDA, Wrong drug strength

Accord Healthcare Levothyroxine Sodium Tablets

Accord Healthcare Levothyroxine Sodium Tablets, USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

4 recalls that day

B. Braun Lactated Ringer's Injection

The product contains particulate matter, identified as cellulose cotton fibers, wood fiber, and polystyrene.

High risk, FDA, Foreign object

Optimal Balance Pharmacy Glutathione Injection

The product has elevated bacterial endotoxin levels.

High risk, FDA, Sterility problem

Golden State Medical Supply Carbamazepine Tablets

The tablets have black specks.

Moderate risk, FDA, Manufacturing problem

Mylan Acamprosate Calcium, Delayed-Release Tablets

Mylan Acamprosate Calcium, Delayed-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

1 recall that day

Taro Carbamazepine Tablets

The tablets have black specks from burnt excipient during manufacturing.

Moderate risk, FDA, Quality problem

2 recalls that day

Amneal PEMRYDI RTU (Pemetrexed Injection)

Pemrydi RTU (pemetrexed injection) has a discolored solution, which can be green to dark green in some vials.

Moderate risk, FDA, Quality problem

Libtayo (Cemiplimab-Rwlc) Injection

Libtayo injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

Shoolin Pharma Chem Sildenafil Citrate and Tadalafil

Shoolin Pharma Chem is recalling its Sildenafil Citrate Usp and Tadalafil Usp because of CGMP deviations, as 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 due to potential contamination.

Moderate risk, FDA, Sterility problem

2 recalls that day

Tyenne (Tocilizumab-Aazg) Injection

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, vein inflammation, and serious blood vessel blockage.

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 that day

Novartis Diovan Tablets

Diovan (valsartan) 160 mg, 90 tablets may not dissolve properly in the body.

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 that day

Zydus Mirabegron Extended-Release Tablets

Mirabegron Extended-Release Tablets contain an impurity that may be present.

Moderate risk, FDA, Drug impurity

2 recalls that day

Victory Medical Center Pharmacy Glutathione Injection

Glutathione (MDV) vials have elevated bacterial endotoxin levels, which could cause fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

High risk, FDA, Sterility problem

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

Central Admixture Pharmacy Services is recalling its Total Parental Nutrition because of incorrect product formulation.

Low risk, FDA, Quality problem

2 recalls that day

Fresenius Kabi Morphine Sulfate Injection

Morphine Sulfate Injection syringes may be mislabeled and contain Dilaudid.

High risk, FDA, Labeling error

Aurobindo Pharma Dicyclomine Hydrochloride Capsules

Dicyclomine Hydrochloride Capsules may be shortfilled, with reports of empty capsules.

Moderate risk, FDA, Quality problem

3 recalls that day

Adequan Canine and Equine Injections

Adequan i.m. and Adequan Canine injections contain glass fibers, which may cause injection site reactions.

Moderate risk, FDA, Contamination

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

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

High risk, FDA, Foreign object

Parnell Techologies Sevoflurane Inhalation Anesthetic for Dogs

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

Not yet rated, FDA

1 recall that day

Glenmark Azelaic Acid Gel

Azelaic Acid Gel, 15% has an abnormal texture or consistency, described as grainy, gritty, or sandy.

Moderate risk, FDA, Manufacturing problem

7 recalls that day

Long Grove Pharmaceuticals Cyclophosphamide for Injection

Cyclophosphamide for Injection contains stainless steel particulate matter that can cause serious adverse events, including death.

High risk, FDA, Foreign object

Baxter Cefazolin in Dextrose Injection

Cefazolin in Dextrose Injection may contain particulate matter, which can cause pulmonary emboli, blood vessel occlusions, and phlebitis.

High risk, FDA, Foreign object

American Regent Nitroglycerin, Cyanocobalamin, Aminocaproic Acid, Atropine Sulfate, Acetylcysteine, Selenious Acid, Multrys, Papaverine HCl, Tralement and Nicardipine Injections

American Regent injections contain particulate matter.

High risk, FDA, Contamination

Micro Labs Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution has defective container with broken cap spikes and undeliverable drops.

Moderate risk, FDA, Packaging defect

Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets

Proin ER, phenylpropanolamine hydrochloride extended-release tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules may contain more impurities than allowed.

Low risk, FDA, Drug impurity, FDA event number 99421

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for Injection USP contains a precipitate.

Moderate risk, FDA, Quality problem

3 recalls that day

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections

Glycopyrrolate Injection, Lidocaine HCl Injection, Naropin, and Xylocaine contain hair.

Moderate risk, FDA, Foreign object

Rohto Cooling Eye Drops

Rohto Cooling Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Precision Dose Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

1 recall that day

Enovachem Pharmaceuticals Lidolog Kit

The Lidolog Kit has a label that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

1 recall that day

Rising Pharma Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets USP 5 mg may be contaminated with ranitidine, which can cause serious adverse events.

High risk, FDA, Contamination

6 recalls that day

Rising Cyproheptadine Hydrochloride Syrup

Cyproheptadine Hydrochloride Syrup has a precipitate, with crystals and particles floating in the bottle.

Moderate risk, FDA, Foreign object

Major Pharmaceuticals Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets, USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Trokendi XR, Topiramate Extended-Release Capsules

Trokendi XR, topiramate extended-release capsules may not dissolve properly in the body.

Low risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran etexilate Capsules 110 mg and 150 mg may contain more impurities than allowed.

Low risk, FDA, Drug impurity, FDA event number 99330