Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Indocin (Indomethacin) suppositories Recalled by G & W Laboratories, Inc. Due to Failed Impurities/Degradation Specifications: Out of specification (OOS) for...
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 G & W Laboratories, Inc. directly.
Affected Products
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43
Quantity: 3456 boxes
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Where Was This Sold?
Within United States
About G & W Laboratories, Inc.
G & W Laboratories, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report