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.
John W Hollis Inc is recalling specific vials of Papaverine, Phentolamine, and Atropine solution due to an incorrect expiration date on the label.
Apotex Inc. is recalling Risperidone Oral Solution because it failed impurity specifications at the 18-month stability time point.
Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.
Genesis Pharmaceuticals is recalling 461 bottles of Glytone Acne Treatment Facial Cleanser due to out-of-specification viscosity results.
GlaxoSmithKline is recalling specific lots of Nicorette Lozenges Mini because they failed quality specifications, including being overly thick, soft, and sub or superpotent.
GlaxoSmithKline is recalling a specific lot of Nicorette Lozenge and NicoDerm CQ combination packs because the lozenges failed quality specifications.
Upsher Smith Laboratories is recalling 36 bottles of Oxandrolone Tablets, USP, 10 mg, because they were packaged without primary labels.
GlaxoSmithKline is recalling specific lots of Nicorette and Nicoderm CQ products because the lozenges failed quality specifications, including being overly thick, soft, and having incorrect potency.
Synthes, Inc. is recalling 20 Hohmann retractors because they were mis-etched with the wrong part number.
Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.
Boehringer Ingelheim is recalling Spiriva HandiHaler capsules because a defective delivery system may cause dose delivery out of specification.
Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.
Hospira Inc. is recalling 237,850 ampoules of Demerol (meperidine HCL) because the immediate container labels are missing. The recall is nationwide.
Ormco is recalling 150 units of Titanium Orthos Brackets because the color identification dot was marked on the wrong tie-wing.
Walong Marketing is recalling Asian Taste Green Tea Pumpkin Seeds because they contain sodium copper chlorophyllin, an ingredient not permitted in U.S. food products.
Technidata S.A. is recalling TDWorkstation software versions 11.01.A and higher because a conflict may cause the system to send incorrect patient demography to connected instruments.
Teva Pharmaceuticals is recalling specific lots of QVAR inhalation aerosol because they failed impurity specifications during stability testing.
Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.
Hill Dermaceuticals is recalling 7,292 bottles of Derma-Smoothe/FS scalp oil because the active ingredient was found to be subpotent during routine testing.
Lin-Zhi International is recalling Norbuprenorphine cutoff calibrators because they failed quality control testing. The product is used for in vitro diagnostic calibration.
Bonduelle USA Inc is recalling bulk totes of frozen cut and whole green beans due to the presence of filth.
TriVascular, Inc. is notifying European physician users of the Ovation Prime Abdominal Stent Graft System about changes to the Instructions for Use.
Hill Dermaceuticals is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Hill Dermaceuticals is recalling DermOtic Oil ear drops because the active ingredient was found to be subpotent during routine testing.
McKesson Packaging Services is recalling 1,557 boxes of Venlafaxine Hydrochloride Extended Release Capsules, 150 mg, due to out-of-specification dissolution results.