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.
Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.
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.
Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.
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.
Driscoll's Inc. is recalling fresh strawberries with pesticide residue (Etoxazole) above U.S. limits. Affected products were distributed to California, Oklahoma, Minnesota, Missouri, Maryland, and possibly Ontario, Canada.
Sun Pharmaceutical is recalling Chlorthalidone Tablets USP 25 mg (Lot #P0602, expiration 03/2023) due to stainless steel microscopic wear particles, punch lubricant oil, and silicone particles from the dust cup found in the product.
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.
Envisiontec US LLC recalled 795 units of FLEXCERA SMILE dental resins manufactured between April 2021 and September 2021 because they were produced in a non-FDA-registered facility and falsely labeled as German origin.
Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.
ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.
Natural Way Cheese Marble Cheese Curds are being recalled because the milk used was stored beyond the required 72-hour tank cleaning interval, creating potential food safety risk.
ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.
ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.
In-Things Corporation is recalling about 200 "Sparkle Sheer Social Wrap" scarves sold online because they fail to meet federal flammability standards for textiles, posing a burn injury risk.
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
ULTRAtab Laboratories is recalling Kramer Novis Tusicof caplets due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 639,729 tablets distributed to three wholesalers.
ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.
ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.
Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.