Class II · Moderate risk Ongoing
Biotin for Injection
Reason Lack of Assurance of Sterility
Is Biotin recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Biotin (15 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Biotin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Ongoing
Biotin 5mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Minoxidil/Biotin 1.25mg/5mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
D-Biotin 300 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I · High risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Reason Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk Terminated
Biotin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Finasteride/Biotin 1 mg/50 mcg
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class III · Low risk Terminated
Biotin 10 mg/mL Injection
Reason Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk Terminated
Biotin Suspension 10mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Biotin USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class I · High risk Terminated
Cap-Biotin 100 Mg
Reason Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class II · Moderate risk Terminated
Biotin10 mg/ml Injectable
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Biotin Injection
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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