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 7 (3%) 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.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg across several lots after routine stability testing returned an out-of-specification result for highest unknown impurity.
Glenmark is recalling 26,928 packs of Viorele desogestrel and ethinyl estradiol tablets from one batch after the product failed impurities and degradation specifications.
Ascend Laboratories is recalling 141,984 bottles of Atorvastatin Calcium Tablets USP 10 mg for failed dissolution specifications.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 40 mg for failed dissolution specifications.
Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 20 mg for failed dissolution specifications.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 80 mg for failed dissolution specifications.
AvKARE is recalling 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets USP from one lot after the product failed content uniformity specifications.
Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets USP 88 mcg after long-term stability testing found assay content below the approved specification range.
Acella Pharmaceuticals is recalling 4,680 five-hundred-count bottles of Doxycycline Hyclate Tablets USP 100 mg after stability testing found the lot did not meet dissolution specifications.
Dr. Reddy's is recalling 571 vials of Succinylcholine Chloride Injection USP after an out-of-specification result for decreased preservative concentration at six-month stability testing.
American Health Packaging is recalling 360 cartons of Carbamazepine Extended-Release Tablets USP 400 mg from one lot after the product failed dissolution specifications.
Zydus is recalling 600 bottles of Entecavir Tablets USP 1 mg from one lot after an individual organic impurity returned an out-of-specification result.
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.
Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.
Weyland Brain Nutrition Lithium Orotate capsules are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.
Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.
Lithium Orotate capsules distributed by Mecene LLC are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.
LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.
Cinacalcet Tablets 90 mg from Strides Pharma are being recalled because they failed dissolution specifications. 6,672 bottles are affected.
Lorazepam Injection USP 2 mg/mL from Hikma is being recalled after an out-of-specification result for total related compounds. 382,775 1 mL vials are affected.
Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.
Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.