Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Johnsonville is recalling approximately 42,062 pounds of Beddar with Cheddar pork sausage links due to possible contamination with thin black plastic fibers.
Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.
Ford recalls 2018-2023 Expedition, Navigator, and F-Series vehicles lacking head restraint adjustment instructions. Improper adjustment increases crash injury risk.
John Deere is recalling about 1,600 XUV590E, XUV590M, and XUV590M S4 Gator utility vehicles because fuel can leak from under the fuel cap, creating a fire hazard. No injuries have been reported.
Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.
Akorn, Inc. is recalling Vitamin D Supplement Drops (400 IU, Cherry Flavored, 50mL) distributed nationwide because the firm ceased operations and could not complete required stability studies.
Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.
Advanced Compounding Solutions is recalling a compounded phenylephrine solution made with 5% Dextrose instead of the correct 0.9% Sodium Chloride diluent. The error affects 198 units distributed nationwide.
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.
Jost Chemical is recalling magnesium citrate dietary ingredient due to yeast and mold levels exceeding specifications. Approximately 73 drums totaling 8,030 pounds distributed to manufacturers in California and Georgia were affected.
Akorn, Inc. recalled all lots of Levofloxacin Oral Solution due to the company going out of business and being unable to continue required stability studies. Patients currently taking this medication should contact their healthcare provider.
Akorn Inc. is recalling all lots of Cromolyn Sodium Ophthalmic Solution, USP 4% due to manufacturing deviations. The firm went out of business and could no longer continue required stability studies.
Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.
Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.
Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.