Hazard
108 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 108 specification failure recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (6%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all specification failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.
Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.
Dr. Reddy's Laboratories is recalling ibuprofen 600 mg tablets for failed tablet specifications. The affected product was distributed nationwide.
Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.
Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.
Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.
Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.
DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.
Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.
DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.
DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.
Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.
Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month timepoint.
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 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.