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 UP AND UP Childrens Acetaminophen oral suspension due to contamination from a recalled excipient used in manufacturing. The product was distributed nationwide.
Perrigo Company PLC is recalling 3,192 bottles of CareOne Severe Congestion Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) distributed nationwide because the products were manufactured with a contaminated excipient that was itself 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 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.
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.
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 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 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 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 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 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.
CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.
ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.
MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.
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.
RED MAMMOTH capsules, 400 mg (Lot # DK1027, Exp. 08/01/2023) are being recalled because they contain undeclared sildenafil and tadalafil, making them an unapproved drug marketed without FDA authorization.
THE RED PILL EXTRA STRENGTH 800 mg capsules are being recalled because they contain undeclared tadalafil, an active ingredient in FDA-approved sexual-enhancement medications. The product was marketed and distributed as an unapproved drug nationwide via Amazon.
Je Dois Lavoir LLC is recalling 365 SKINNY High Intensity Capsules (600 mg, 30-count bottles) because the product contains undeclared sibutramine, a drug previously withdrawn from the US market due to safety concerns.
STAQ Pharma is recalling HYDROmorphone HCl PF syringes (lot 21104221A) that were incorrectly labeled as Morphine Sulfate PF. The mislabeling affects approximately 905 syringes distributed in Colorado, Ohio, and Texas.
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx Joint Cream is being recalled due to microbial contamination identified as Pluralibacter gergoviae in a non-sterile product.
ANI Pharmaceuticals is voluntarily recalling Alprazolam Tablets USP 0.5 mg in multiple package sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 205,662 bottles distributed across the United States.
ANI Pharmaceuticals has recalled Alprazolam Tablets USP 1.0 mg distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 173,499 bottles across multiple lot numbers.
ANI Pharmaceuticals, Inc. has recalled Pyrazinamide Tablets USP 500 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5,477 bottles distributed nationwide.
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