Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ibuprofen Caplets USP 200 mg Recalled by Time-Cap Laboratories, Inc. Due to CGMP Deviations: Various strengths of ibuprofen tablets/caplets are...

Date: January 11, 2018
Company: Time-Cap Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

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 Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, 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.

Affected (51 states)Not affected

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