Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.
Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.
BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.
Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.
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.
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.
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
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 UP AND UP Childrens Acetaminophen oral suspension due to contamination from a recalled excipient used in manufacturing. The product was distributed nationwide.
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.
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.
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 PLC is recalling NASAL Maximum Strength Nasal Spray (oxymetazoline HCl 0.05%) due to manufacturing with a contaminated excipient that was itself recalled from the supplier. The recall affects one batch distributed nationwide.
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.
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.
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.
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 Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.
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 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 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.
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.
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 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.