Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Ethambutol Hydrochloride Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: This product is being recalled...
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Quantity: 4896 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report