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.
Dollar Tree Distribution is recalling all over-the-counter drug products sold by Family Dollar retail stores in six states due to potential rodent exposure at a distribution center.
TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.
Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.
Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.
HEB 50% Isopropyl Alcohol First Aid Antiseptic bottles contain 3% Hydrogen Peroxide instead due to a label mix-up. The front label incorrectly identifies the product as isopropyl alcohol when the contents are actually a hydrogen peroxide topical solution.
Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir USP 0.5 mg/5 mL nationwide due to unknown impurities found at higher than permissible levels in affected lots.
RISE UP RED EDITION Capsules, 650 mg, have been recalled because they contain undeclared tadalafil, an ingredient found in FDA-approved male sexual enhancement products. The product is an unapproved drug and was distributed nationwide via Amazon Marketplace.
Perrigo is recalling Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that was recalled from the supplier.
Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.
Perrigo Company is recalling Equate Children's Pain and Fever acetaminophen suspension due to contamination from a recalled excipient used during manufacturing. The affected batch was distributed nationwide.
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) nationwide due to manufacturing with a contaminated excipient that was itself recalled by the supplier.
Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) oral suspension due to use of contaminated excipient during manufacturing. The product was distributed nationwide in the United States.
Perrigo Company PLC is recalling Rugby Children's Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that had been recalled from the supplier.
AMS Packaging Inc is recalling Premium Nature Instant Hand Sanitizer (70% ethyl alcohol) in 8 oz and 16 oz bottles because some bottles contain less ethanol than labeled, reducing effectiveness.
Perrigo Company is recalling DG Health Nasal (Oxymetazoline Hydrochloride) nasal spray because it was manufactured with a contaminated excipient obtained from a recalled supplier.
Perrigo Company is recalling NASAL oxymetazoline HCl nasal spray nationwide due to contaminated excipient used in manufacturing. The affected product was distributed to retailers including Kroger.
Perrigo Company is recalling DG Health Children's Pain and Fever (acetaminophen) oral suspension because the product was manufactured with a contaminated excipient that was itself recalled by its supplier.
Dr. Reddy's Laboratories is recalling Bortezomib 3.5 mg single-dose vials nationwide due to failed stability specifications. Approximately 2,980 vials of lot H210233 (expiration 3/1/2023) are affected.
Perrigo Company PLC is recalling approximately 10,800 bottles of NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%) nationwide due to manufacturing with a contaminated excipient supplied by their ingredient vendor.
Perrigo Company is recalling 561 bottles of Children's Pain & Fever Acetaminophen 160 mg per 5 mL oral suspension due to contamination from a recalled excipient ingredient used during manufacturing.
Dr. Reddy's Laboratories is recalling Azacitidine 100mg vials distributed nationwide due to failed stability specifications. The recall affects six lots with expiration dates ranging from August 2023 to April 2024.
TopCare Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) manufactured by Perrigo Company PLC is being recalled nationwide because the product was made with a contaminated excipient that was itself recalled by the supplier. Consumers should stop using affected batches.
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