Hazard
261 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 261 out of specification recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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 out of specification 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.
Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.
Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.
Sun Pharmaceutical Industries is recalling Clindamycin Phosphate Topical Solution 1% after out of specification results for total impurities and for assay.
Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.
AvKARE is recalling 7,991 cartons of Rosuvastatin Tablets, USP 10 mg, because the product was out of specification for dissolution.
Alembic Pharmaceuticals is recalling Fesoterodine Fumarate Extended-release Tablets, 8 mg, because levels of a diester impurity exceeded the specification limit.
Draeger is recalling 188 Vapor 3000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.
Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.
Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.
Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.
Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.
Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.
Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.
Cipla USA is recalling Lanthanum Carbonate chewable tablets, 1000mg, after the product failed stability specifications with an out of specification hardness test result.
Breckenridge Pharmaceutical is recalling 7,389 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.
Breckenridge Pharmaceutical is recalling 3,397 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.
Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.
Cipla Limited is recalling 4,438 cartons of Phytonadione Injectable Emulsion, USP 10mg/mL, after the product failed stability specifications with out-of-specification colour index results.
Cepheid is recalling 9,880 Xpert MTB/RIF cartridges from one lot because product testing did not meet expected stability criteria.
Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.