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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).
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6 recalls that day

Bionpharma Divalproex Sodium Delayed-Release Tablets

Divalproex Sodium Delayed-Release Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

1 recall that day

BD ChloraPrep Clear

BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.

Moderate risk, FDA, Sterility problem

2 recalls that day

Chiesi Cleviprex Clevidipine Injectable Emulsion

Cleviprex injectable emulsion lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Bell Pharmaceuticals Carbamide Peroxide Ear Drops

Bell Pharmaceuticals Carbamide Peroxide Ear Drops are subpotent, with low pH and significantly reduced assay.

Moderate risk, FDA, Wrong drug strength

2 recalls that day

Padagis Nystatin Cream

Nystatin Cream USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Sun Pharmaceutical Fexofenadine Hydrochloride Tablets

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine may contain more impurities than allowed.

Low risk, FDA, Drug impurity

2 recalls that day

Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection

Reliance Life Sciences Private products lack sterility assurance.

Moderate risk, FDA, Manufacturing problem

Gasco and Drogueria San Juan Isopropyl Alcohol

Gasco and Drogueria San Juan Isopropyl Alcohol may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

4 recalls that day

QuVa Pharma Methohexital Sodium

Methohexital Sodium failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

Medline Remedy Specialized Silicone Cream (Hydraguard-D)

Medline Remedy Specialized Silicone Cream (Hydraguard-D) may contain more impurities than allowed.

Moderate risk, FDA, Quality testing problem

Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient

The product has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Avet Methohexital Sodium for Injection

Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

3 recalls that day

Cipla Cinacalcet Hydrochloride Tablets

The tablets contain N-nitroso-cinacalcet above the acceptable daily intake.

Moderate risk, FDA, Drug impurity

Lannett Dextroamphetamine and Amphetamine Extended-Release Capsules

Extended-release capsules labeled as such contain only immediate-release pellets.

Moderate risk, FDA, Labeling error

Enovachem Pharmaceuticals Lidocaine HCl Injection

Accucaine kits and Lidocaine HCl Injection lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

Lupin Pharmaceuticals Glucagon Emergency Kit for Low Blood Sugar

The kit has a CGMP deviation: an out-of-specification result in the gliding force functionality test during stability testing.

Moderate risk, FDA, Quality testing problem

Hikma Gemcitabine Injection

Gemcitabine Injection was stored incorrectly.

Moderate risk, FDA, Processing problem

3 recalls that day

Synjardy XR Tablets (Empagliflozin and Metformin Hydrochloride Extended-Release Tablets)

An incorrect detergent was used and required swab sampling was not performed on a production hopper.

Moderate risk, FDA, Manufacturing problem

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Lupin Prednisolone Acetate Ophthalmic Suspension

The ophthalmic suspension contains a foreign substance.

Moderate risk, FDA, Foreign object

2 recalls that day

CareFusion 213 BD ChloraPrep and PurPrep Applicators

CareFusion 213 BD ChloraPrep and PurPrep Applicators may lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Accord BioPharma Imuldosa Injection

Imuldosa injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall that day

MFV Compounding Pharmacy Diclofenac Sodium Eye Ointment

Diclofenac Sodium 0.1% Eye Ointment contains Bacillus cereus.

High risk, FDA, Contamination

1 recall that day

Povi-One, 10% Povidone-Iodine Oral Antiseptic

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

Moderate risk, FDA, Wrong drug strength

5 recalls that day

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

Incorrect product formulation: bag did not contain copper and famotidine per label.

Moderate risk, FDA, Labeling error

Sun Pharmaceutical Perampanel CIII Tablets

Perampanel CIII Tablets labeled 6mg may contain a 10mg tablet.

Moderate risk, FDA, Labeling error

Camber Lacosamide Tablets

Lacosamide Tablets may contain a foreign tablet, Selexipag.

Moderate risk, FDA, Foreign object

ANI Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution

HydrOXYzine Hydrochloride Oral Solution contains a foreign substance.

Low risk, FDA, Foreign object

PReye Vitamin See Antioxidant Preservative Free Eye Drops

PReye Vitamin See Antioxidant Preservative Free Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls that day

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

Amgen is recalling its Corlanor (ivabradine) tablets because of the presence of foreign substance.

Moderate risk, FDA, Foreign object

2 recalls that day

Major Methylergonovine Maleate Tablets

Major Methylergonovine Maleate Tablets, USP, 0.2 mg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Ajanta Pharma Fenofibrate Capsules

The product has CGMP deviations.

Moderate risk, FDA, Manufacturing problem

1 recall that day

Keystone Topical Anesthetic Gels

Keystone Topical Anesthetic Gels may come in containers with incomplete seals.

Moderate risk, FDA, Packaging defect

1 recall that day

Endo Buprenorphine HCl Injection

Buprenorphine HCl injection can crystallize, identified as Buprenorphine free base.

Moderate risk, FDA, Quality problem

1 recall that day

Ajanta Pharma Aripiprazole Tablets

Aripiprazole Tablets USP 30 mg are mislabeled, containing Voriconazole Tablets 50 mg instead.

Moderate risk, FDA, Labeling error

6 recalls that day

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments

Antifungal athlete's foot cream and other ointments and creams have manufacturing problems.

Moderate risk, FDA, Manufacturing problem

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets, USP, 25 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Sandoz Focalin XR Extended-Release Capsules

Sandoz is recalling its Focalin XR (dexmethylphenidate HCl) because of 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

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

IntegraDose Compounding Services Vasopressin Syringes

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

VistaPharm Kerr Insta-Char Activated Charcoal

Kerr Insta-Char in aqueous or sorbitol base with cherry flavor does not meet the OTC Monograph.

Moderate risk, FDA, Quality testing problem

1 recall that day

Golden State Medical Supply Niacin Extended-Release Tablets

Niacin Extended-Release Tablets, USP, 1,000 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

3 recalls that day

Amneal Primidone Tablets

Primidone Tablets may be cross-contaminated with another drug.

Low risk, FDA, Contamination

Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets

Minocycline Hydrochloride Extended-Release Tablets failed a dissolution test.

Moderate risk, FDA, Drug dissolving problem

Zep Alcohol Sanitizer Spray

Zep Alcohol Sanitizer Spray has microbial contamination of sterile products.

Moderate risk, FDA, Sterility problem

1 recall that day

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 that day

Sun Pharmaceutical Industries Budesonide Inhalation Suspension

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

Moderate risk, FDA, Foreign object

Breckenridge Duloxetine Delayed-Release Capsules

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

Moderate risk, FDA, Drug impurity

1 recall that day

BD ChloraPrep Clear Applicators

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

High risk, FDA, Sterility problem