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Drug recalls

Drug recalls from FDA, newest first.
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3 recalls

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Lupin Prednisolone Acetate Ophthalmic Suspension

The ophthalmic suspension contains a foreign substance.

Moderate risk, FDA, Foreign object

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

2 recalls

CareFusion 213 BD ChloraPrep and PurPrep Applicators

BD ChloraPrep and PurPrep applicators may be unsterile or contaminated with fungus, potentially causing serious infection or death.

Moderate risk, FDA, Sterility problem

Accord BioPharma Imuldosa Injection

Imuldosa injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls

TNVitamins Organic Moringa Capsules and Powder

TNVitamins 100% Organic Moringa Capsules and Powder are contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

MFV Compounding Pharmacy Diclofenac Sodium Eye Ointment

Diclofenac Sodium 0.1% Eye Ointment contains Bacillus cereus.

High risk, FDA, Contamination

1 recall

Povi-One, 10% Povidone-Iodine Oral Antiseptic

Povi-One, 10% Povidone-Iodine Oral Antiseptic has sub potency.

Moderate risk, FDA, Wrong drug strength

4 recalls

Sun Pharmaceutical Perampanel CIII Tablets

Perampanel CIII Tablets, 6mg, may contain a 10mg tablet due to a label mix-up.

Moderate risk, FDA, Labeling error

Camber Lacosamide Tablets

Lacosamide Tablets may contain a foreign tablet, Selexipag 1000 mcg.

Moderate risk, FDA, Foreign object

ANI Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution

HydrOXYzine Hydrochloride Oral Solution contains a foreign substance.

Low risk, FDA, Foreign object

Abbott Determine HIV 1/2 Ag/Ab Combo

Abbott Diagnostics has noticed a negative trend in false positive complaints for Determine" HIV 1/2 Ag/Ab Combo 25T kits (Catalog 7D2648).

Moderate risk, FDA

2 recalls

Direct Rx Duloxetine and Cymbalta Capsules

Duloxetine D/R contains an impurity above the FDA recommended interim limit.

Moderate risk, FDA, Drug impurity

Amgen Corlanor and Sensipar Tablets

Corlanor (ivabradine) tablets contain a foreign substance, and Sensipar (cinacalcet) Tablets have CGMP deviations.

Moderate risk, FDA, Foreign object

2 recalls

Major Methylergonovine Maleate Tablets

Methylergonovine Maleate Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Ajanta Pharma Fenofibrate Capsules

Fenofibrate Capsules, USP 200 mg, have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

1 recall

Keystone Topical Anesthetic Gels

Topical anesthetic gels may have defective containers with incomplete seals.

Moderate risk, FDA, Packaging defect

1 recall

Endo Buprenorphine HCl Injection

Buprenorphine HCl injection has crystallization identified as Buprenorphine free base.

Moderate risk, FDA, Quality problem

1 recall

Ajanta Pharma Aripiprazole Tablets

Aripiprazole Tablets USP are mislabeled, containing Voriconazole Tablets instead.

Moderate risk, FDA, Labeling error

6 recalls

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets fail dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Sandoz Focalin XR Extended-Release Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date.

Low risk, FDA, Labeling error

Glenmark Alyacen 7/7/7 and Norethindrone and Ethinyl Estradiol Tablets

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Moderate risk, FDA, Drug impurity

IntegraDose Compounding Services Vasopressin Syringes

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride is subpotent.

Moderate risk, FDA, Wrong drug strength

VistaPharm Kerr Insta-Char Activated Charcoal

KERR INSTA-CHAR activated charcoal products did not meet the OTC Monograph.

Moderate risk, FDA, Quality testing problem

3 recalls

Amneal Primidone Tablets

Primidone Tablets, USP, 50 mg may be cross-contaminated with Acemetacin API.

Low risk, FDA, Contamination

Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets

Minocycline Hydrochloride Extended-Release Tablets failed dissolution specifications during testing.

Moderate risk, FDA, Drug dissolving problem

Zep Alcohol Sanitizer Spray

Zep is recalling its Alcohol Sanitizer Spray because of microbial contamination of sterile products.

Moderate risk, FDA, Sterility problem

1 recall

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse

Saline nasal spray may contain Aspergillus spp. and could cause serious infections in at-risk people.

High risk, FDA, Contamination

2 recalls

Sun Pharmaceutical Industries Budesonide Inhalation Suspension

Budesonide Inhalation Suspension contains black or brown specs and particles in the solution.

Moderate risk, FDA, Foreign object

Breckenridge Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.

Moderate risk, FDA, Drug impurity

1 recall

BD ChloraPrep Clear Applicators

BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.

High risk, FDA, Sterility problem

1 recall

Fresenius Kabi Epinephrine Injection

Epinephrine Injection failed impurities and degradations specifications.

Low risk, FDA, Drug impurity

1 recall

Gas-X Extra Strength Softgels

Gas-X Extra Strength Softgels may be contaminated with a diluted propylene glycol-based coolant, which could cause nausea, vomiting, abdominal pain.

High risk, FDA, Chemical contamination

4 recalls

Lannett Niacin Extended-Release Tablets

Niacin Extended-release Tablets failed dissolution specifications during stability testing.

Moderate risk, FDA, Drug dissolving problem

Guardian Drug Antacid Tablets

Antacid tablets contain small metallic particles.

Moderate risk, FDA, Foreign object

Forte BioPharma Xyvona (Levorphanol Tartrate Tablets)

Xyvona (levorphanol tartrate tablets) has a labeling issue and is not marketed under the proprietary name.

Moderate risk, FDA, Labeling error

Asclemed USA Duloxetine DR Capsules

Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.

Moderate risk, FDA, Drug impurity

2 recalls

Spectra Medical Devices Lidocaine HCl Injection

Lidocaine HCl Injection USP may lack sterility.

Moderate risk, FDA, Sterility problem

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets have failed dissolution specifications, with olmesartan medoxomil content below specifications.

Moderate risk, FDA, Drug dissolving problem

1 recall

Eugia Lidocaine HCl Injection

Lidocaine HCl Injection has a label wrap that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

1 recall

Better Weather Actives Fix Elixir

Better Weather Fix Elixir may contain undeclared Mitragynine and Mitragynine Pseudoindoxyl, which can cause nausea, vomiting, and other effects.

FDA

1 recall

AbbVie Pred Mild Ophthalmic Suspension

Pred Mild ophthalmic suspension failed stability specifications.

Low risk, FDA, Quality testing problem

1 recall

Aveva Nicotine Transdermal System Patch

The patch failed impurity tests due to elevated oxidative-related impurities.

Low risk, FDA, Drug impurity

1 recall

Mogo Pure Moringa Oleifera Capsules

Moringa capsules may be contaminated with Salmonella Typhimurium.

High risk, FDA, Salmonella

1 recall

Lloyd ToxiBan Charcoal-Kaolin Suspension

ToxiBan Charcoal-Kaolin Suspension has microbial levels exceeding specification limits.

Moderate risk, FDA, Contamination

1 recall

IntegraDose Compounding Services Fentanyl Citrate Injection

FentaNYL Citrate injection is subpotent.

Moderate risk, FDA, Wrong drug strength

3 recalls

ANI Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

UCB Cimzia Prefilled Syringes

Cimzia (certolizumab pegol) prefilled syringes lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Zydus Erythromycin Tablets

Zydus Pharmaceuticals is recalling its Zydus Erythromycin Tablets, USP because of CGMP deviations and presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.

Moderate risk, FDA, Drug impurity