Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cephalexin Capsules Recalled by Caraco Pharmaceutical Laboratories, Ltd. Due to CGMP Deviations: These products are being recalled because...
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 Caraco Pharmaceutical Laboratories, Ltd. directly.
Affected Products
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Quantity: a) 43,585 bottles; b) 296,968 bottles
Why Was This Recalled?
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Caraco Pharmaceutical Laboratories, Ltd.
Caraco Pharmaceutical Laboratories, Ltd. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report