Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule recall — FDA D-0659-2026
Lack of Assurance of Sterility
Complete FDA and NHTSA recall records dated in 2026, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Lack of Assurance of Sterility
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of Assurance of Sterility
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Elevated coliforms
Potential contamination with plastic material
Product may be contaminated with Clostridium botulinum.
undeclared colors (yellow#5)
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Dietary supplement product Vista MAX contains undeclared Yellow#5.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.