Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.
Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.
High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.
Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.
Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.
Dr. Reddy's Laboratories is recalling Tizanidine HCl 4 mg tablets nationwide because some tablets are shaved, failing the required tablet specification.
Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
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