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.
Perrigo Company is recalling 1,296 bottles of Basic Care No Drip Nasal Spray (oxymetazoline hydrochloride 0.05%) distributed nationwide due to contaminated excipient used during manufacturing.
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 is recalling 37,104 bottles of Basic Care No Drip Nasal Spray (oxymetazoline hydrochloride 0.05%) nationwide due to contaminated excipient used during manufacturing. The affected batches were distributed to U.S. consumers.
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 is recalling Good Sense Pain and Fever acetaminophen child oral suspension (160mg/5ml, 4 FL OZ bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by the supplier.
Perrigo Company is recalling Equate Children's Pain and Fever (Acetaminophen) oral suspension nationwide due to manufacturing deviations involving contaminated excipient from a supplier.
Perrigo Company is recalling CareOne Severe Congestion Nasal Spray due to contaminated excipient used during manufacturing. The nasal spray was made with an excipient that had been recalled from the supplier.
Target-distributed Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) is being recalled because it was manufactured with a contaminated excipient that was itself 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 Severe Congestion Nasal Spray, No Drip Plus Menthol because the product was manufactured with a contaminated excipient that was recalled from the supplier.
Perrigo Company PLC is recalling UP AND UP Children's Acetaminophen Oral Suspension (160mg/5ml, 4 FL OZ bottles) because the product was manufactured with a contaminated excipient that was recalled by the supplier. The recall affects approximately 26,832 bottles distributed nationwide.
Perrigo Company PLC is recalling UP AND UP Acetaminophen Infant Dye Free Grape Oral Suspension due to use of a contaminated excipient supplied by an outside vendor. The product was distributed nationwide.
Premium Nature Instant Hand Sanitizer is being recalled nationwide because some bottles were found to contain subpotent levels of ethanol. The FDA identified the issue during analysis of multiple bottle sizes.
Professional Disposables International is recalling Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) due to unvalidated test methods used during manufacturing. The company has not reported any illnesses or injuries.
Basic Care No Drip Nasal Spray (oxymetazoline HCl) is being recalled because it was manufactured with a contaminated excipient that had been recalled from the supplier. The recall affects 26,448 bottles distributed nationwide.
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.
Professional Disposables International, Inc. is recalling Prevantics Swab (chlorhexidine gluconate and isopropyl alcohol) due to cGMP deviations involving inadequate validation of manufacturing test methods. The product was distributed nationwide in the USA and Puerto Rico.
Perrigo Company PLC is recalling DG Health Nasal Spray (Oxymetazoline HCl 0.05%) distributed nationwide because the product was manufactured with a contaminated excipient that was itself recalled from the 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 Soothing 12 Hour Nasal Decongestant Spray nationwide because the product was manufactured with a contaminated excipient that was recalled from the supplier.
Perrigo Company is recalling DG Health Nasal (Oxymetazoline Hydrochloride) nasal spray because it was manufactured with a contaminated excipient obtained from a recalled supplier.
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.
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) due to use of a contaminated excipient. The product was manufactured with a recalled ingredient from the excipient supplier.
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.
Pharmasol Corporation is recalling Lung Cleaner (saline eucalyptus) inhalers in 37 oz cans due to current good manufacturing practice (cGMP) deviations identified during production.
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