Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets due to failed stability testing. The product was distributed throughout the United States.
Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.
Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.
Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.
PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.
Morton Salt Inc. is recalling 22,284 units of Morton Natural Sea Salt because iodized sea salt was packaged in the wrong containers.
Akorn, Inc. is recalling specific lots of Azelastine HCl Ophthalmic Solution 0.05% because of out-of-specification results for Azelastine N-oxide.
Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.
Mayne Pharma is recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets due to a lot number labeling error on the primary container.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Valsartan 40 mg tablets because an incorrect grade of excipient may have been used during manufacturing.
Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.
Gourmet International Inc. is voluntarily recalling LItaly Sparkling Lemon Juice Drink because of reports of leaking caps.
Jubilant Cadista Pharmaceuticals is recalling 18,947 bottles of Valsartan 160 mg tablets because an incorrect grade of excipient may have been used during manufacturing.
Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.
Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.
Gourmet International Inc. is voluntarily recalling LItaly Sparkling Lime Juice Drink due to packaging concerns and reports of leaking caps.
Gourmet International Inc. is voluntarily recalling L'Italy Sparkling Pomegranate Juice Beverages due to packaging concerns and reports of leaking caps.
Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
Gourmet International Inc. is voluntarily recalling L'Italy Sparkling Mandarin Juice Drink because of packaging concerns and reports of leaking caps.
Gourmet International Inc. is voluntarily recalling L'Italy Sparkling Grapefruit Juice Drink because of packaging concerns and reports of leaking caps.
Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.