Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Is Rocuronium recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Rocuronium (27 total). Check the affected lots below.
Most common reason: Sterility / contamination (18 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rocuronium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Rocuronium recalls on record
none so far in 2026; 27 on record, newest first
Class II · Moderate risk
Rocuronium Bromide Injection
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
rocuronium
Lack of assurance of sterility:
Class II · Moderate risk
rocuronium 50 mg/5 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium50 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
ROcuronium Bromide 50 mg/5 mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection 50mg/5 mL
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Class II · Moderate risk
Rocuronium Br 50 mg/5mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Rocuronium Br 100 mg/10mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
rocuronium Bromide
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
rocuronium Bromide 10 mg per mL 50 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
10 mg/mL Rocuronium Bromide
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
Rocuronium Bromide in all strengths
Lack of sterility assurance.
Class II · Moderate risk
ROCuronium Bromide 10 mg per mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Rocuronium Bromide Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Rocuronium Bromide all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Rocuronium Bromide 50 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium 10 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide 50 MG/5ML INJ.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Rocuronium 10 mg/mL
Stability data does not support expiry.
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