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 Equate infant's acetaminophen oral suspension due to manufacturing deviations involving a contaminated excipient from a supplier. The product was distributed nationwide.
Perrigo Company is recalling Maximum Strength No Drip Nasal Spray containing oxymetazoline HCl 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 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.
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 Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.
Dr. Reddy's Laboratories is recalling Azacitidine 100mg injectable vials nationwide due to failed stability specifications. Multiple lot numbers distributed across the United States are affected.
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 Children's Pain and Fever (acetaminophen) oral suspension because the product was manufactured with a contaminated excipient that was itself recalled by its 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.
Pharmasol Corporation is recalling Lung Cleaner (saline eucalyptus) inhalers in 37 oz cans due to current good manufacturing practice (cGMP) deviations identified during production.
Perrigo Company is recalling Infants Pain and Fever Acetaminophen Infant Dye Free Grape Oral Suspension due to contaminated excipient used in manufacturing. The recall affects 1,296 bottles distributed nationwide.
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.
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 is recalling Children's Pain and Fever (Acetaminophen) Oral Suspension distributed by Kroger nationwide due to manufacturing with a contaminated excipient. The product was made with an ingredient sourced from a supplier that had recalled that same excipient.
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.
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.
Perrigo Company PLC is recalling Signature Care Nasal Decongestant because the product was manufactured with a contaminated excipient that was itself recalled by its supplier. The recall affects approximately 14,784 bottles distributed nationwide.
CVS Pharmacy is recalling Infant's Grape Flavored Acetaminophen Oral Suspension nationwide because the product was manufactured with a contaminated excipient that was recalled from its supplier.
Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) nationwide due to out-of-specification assay results indicating the product contains less active ingredient than labeled.
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.
Rising Pharmaceuticals is voluntarily recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, due to a tablet size defect. One tablet in a sealed bottle was found to be twice the size of other tablets in the same bottle.
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.
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 is recalling Target Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%) because it was manufactured with a contaminated excipient that had been recalled from the supplier.
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