Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Teva Ethambutol Hydrochloride Tablets Recalled by Teva Pharmaceuticals USA Due to CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA directly.
Affected Products
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Quantity: 10405 tablets
Why Was This Recalled?
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report