Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ibuprofen Tablets USP 800 mg Recalled by Time-Cap Laboratories, Inc. Due to CGMP Deviations: Various strengths of ibuprofen tablets/caplets are...
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 Time-Cap Laboratories, Inc. directly.
Affected Products
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Quantity: N/A
Why Was This Recalled?
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Time-Cap Laboratories, Inc.
Time-Cap Laboratories, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report