Most common reason: Wrong potency / content (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ethambutol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
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