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 Equaline Nasal Spray (oxymetazoline HCl 0.05%) due to manufacturing with a contaminated excipient obtained from a recalled supplier. The recall affects approximately 2,664 bottles distributed nationwide.
Perrigo is recalling Good Sense Children's Pain and Fever acetaminophen oral suspension (160 mg/5 ml) in 4 FL OZ bottles due to contaminated excipient used during manufacturing. The recalled batch 1CK0963 (expiration 12/31/2022) was distributed nationwide.
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.
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.
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 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 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.
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.
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.
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 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 Severe Congestion Nasal Spray, No Drip Plus Menthol because the product was manufactured with a contaminated excipient that was recalled from the supplier.
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 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 is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray due to contamination from a recalled excipient used during manufacturing. The product was distributed nationwide.
Perrigo Company is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) oral suspension nationwide due to CGMP deviations. The product was manufactured with a contaminated excipient that was recalled from the supplier.
Perrigo Company PLC is recalling Nasal Maximum Strength Nasal Spray (Oxymetazoline HCl 0.05%) due to contamination from a recalled excipient used during manufacturing. Approximately 2,302 bottles were distributed nationwide.
Perrigo Company PLC is recalling approximately 64,512 bottles of NASAL MIST oxymetazoline nasal decongestant distributed nationwide because they were manufactured with a contaminated excipient recalled from the supplier.
Perrigo Company is recalling Equate Children's Pain and Fever Acetaminophen Suspension (160mg/5ml) due to contaminated excipient used in manufacturing. Approximately 117,552 bottles distributed nationwide are affected.
Perrigo Company PLC is recalling 1,560 bottles of Equaline Nasal No Drip Nasal Spray nationwide due to contaminated excipient used during manufacturing. The contaminated ingredient was sourced from a recalled excipient supplier.
Perrigo is recalling Acetaminophen Oral Suspension Grape Flavor (160 mg/5 mL, 16 fl oz bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by the excipient supplier.
Perrigo Company PLC is recalling TOPCARE NASAL (Oxymetazoline HCl 0.05%) nasal spray nationwide because products were manufactured with a contaminated excipient obtained from a supplier whose material was recalled.
BayCare Central Pharmacy is recalling 1,157 bags of norepinephrine bitartrate 16 mg in 250 mL saline solution distributed in Florida because the drug is subpotent—meaning it contains less active ingredient than labeled.
Revive Rx is recalling HCG 6,000iu injectable medication due to bacterial contamination (Paenibacillus lautus) identified in the product. The affected lot was distributed nationwide.
STAQ Pharma is recalling a limited number of syringes labeled as Morphine Sulfate PF that actually contain HYDROmorphone HCl PF due to a labeling error. The affected lot was distributed to Colorado, Ohio, and Texas.
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