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.
Advanced Pharma Inc. is recalling all lots of Hydromorphone HCl because the product labeling does not properly disclose that it may contain synthetic or natural latex.
Advanced Pharma Inc. is recalling all Epinephrine HCl products because they may contain latex but lack appropriate labeling.
Advanced Pharma Inc. is recalling all Gentamicin Sulfate products due to a labeling error regarding potential latex content.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Ondansetron HCl because the product labeling may not adequately disclose the presence of synthetic or natural latex.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Neostigmine Methylsulfate because the product may contain latex without proper labeling.
Advanced Pharma Inc. is recalling Labetalol HCl products because labels may not properly disclose the presence of synthetic or natural latex.
Advanced Pharma Inc. is recalling all lots of Penicillin G Potassium because the product may contain latex but lacks appropriate labeling.
Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.
Mylan Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to chemical contamination from paint thinner vapors during facility repairs.
Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.
Advanced Pharma Inc. is recalling Bupivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not properly labeled.
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.
Cell Distributors is recalling Refresh Tears eye drops because the product labels lack an NDC number, net weight, and Drug Facts Panel.
Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.
Advanced Pharma Inc. is recalling NOVA PeriCapsular injection because the product may contain synthetic or natural latex, which is not clearly labeled.
St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.
Advanced Pharma Inc. is recalling Betamethasone Sodium Phosphate & Betamethasone Acetate products because they may contain latex but lack appropriate labeling.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Glycopyrrolate because the product may contain synthetic or natural latex.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Nitroglycerin because the product labeling may not correctly disclose the presence of synthetic or natural latex.
Advanced Pharma Inc. is recalling Methohexital Sodium because the product may contain latex but lacks proper labeling.
Advanced Pharma Inc. is recalling RECK PeriCapsular injection because the product may contain synthetic or natural latex, which is not clearly labeled.
Teleflex Medical is recalling 19,043 units of PE Connector 5 In 1 catheter accessories because the expiration date is missing from the labeling, creating a risk that expired product may be used.
Advanced Pharma Inc. is recalling all Lidocaine products because they may contain latex but lack appropriate labeling.
Advanced Pharma Inc. is recalling Ofirmev (Acetaminophen) injection because the product may contain synthetic or natural latex, which is not currently classified in the labeling.
Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Straight 20/BX because the expiration date is missing from the labeling, creating a risk that expired product may be used.