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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Time-Cap Laboratories, Inc.: Ibuprofen Tablets and Caplets Recalled for Unusual Odor

Agency Publication Date: April 22, 2018
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Summary

Time-Cap Laboratories, Inc. is recalling various strengths of Ibuprofen tablets and caplets due to manufacturing deficiencies that resulted in consumer complaints of an unusual odor. This recall includes 200 mg, 400 mg, 600 mg, and 800 mg strengths sold in various bottle sizes ranging from 50 to 1000 count. These products were manufactured by Marksans Pharma, Ltd. in India and distributed nationwide across the United States. Consumers should check their medicine cabinets for the specific brands and lot numbers affected and contact their healthcare provider for any health-related concerns.

Risk

The recall was initiated because the medications did not meet Current Good Manufacturing Practice (CGMP) standards, resulting in an noticeable odor that could indicate quality or stability issues. While no specific injuries were reported in the announcement, medications that do not meet quality standards may not perform as intended or could contain unintended chemical variations.

What You Should Do

  1. Check your medicine bottles for Ibuprofen Tablets or Caplets (200mg, 400mg, 600mg, or 800mg) from brands including Time Cap Labs, Drug Mart, Food Fair, or Bi-Coastal Pharma International.
  2. Verify the NDC (National Drug Code) and Lot Numbers on the packaging. Affected 200mg tablets include NDC 49483-601-05 (Lot D167C), NDC 49483-601-01 (Lot D172C, H057C), and NDC 53943-291-15 (Lots D167C, E135C).
  3. For 400mg tablets, look for NDC 49483-602-01 (Lots M104C, L016C, H092C, H093C) or NDC 42582-111-18 (Lots C128C, C129C).
  4. For 600mg tablets, check NDC 49483-603-01 (Lots C135C, D044C, D045C, D038C, F069C, H095C) or NDC 42582-112-10 (Lots D044C, D038C, D043C).
  5. For 800mg tablets, check NDC 49483-604-01 (Lots C139C, C140C, F044C) or NDC 42582-113-10 (Lot C140C). For Caplets 200mg, check for Lot F066C across all sizes.
  6. Immediately stop using the recalled medication and contact your healthcare provider or pharmacist for guidance on an alternative treatment.
  7. Return any unused product to the pharmacy or place of purchase for a refund and contact Time-Cap Laboratories at their Farmingdale, NY location for further instructions.
  8. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall instructions for refund and safety.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ibuprofen Tablets, USP, 200 mg (50, 100, 500, 1000, and Bulk bottles)
Model:
NDC 49483-601-05
NDC 49483-601-01
NDC 49483-601-50
NDC 49489-601-10
NDC 49483-601-00
Lot Numbers (62):
D167C (Exp 2/18)
D172C (Exp 2/18)
H057C (Exp 6/18)
D164C (Exp 2/18)
E135C (Exp 3/18)
F004C (Exp 5/18)
D175C (Exp 2/18)
D176C (Exp 2/18)
D177C (Exp 2/18)
D178C (Exp 2/18)
D179C (Exp 2/18)
D180C (Exp 2/18)
D162C (Exp 2/18)
D163C (Exp 2/18)
D164C (Exp 2/18)
D165C (Exp 2/18)
D166C (Exp 2/18)
D168C (Exp 2/18)
D169C (Exp 2/18)
D170C (Exp 2/18)
D171C (Exp 2/18)
D173C (Exp 2/18)
E104C (Exp 2/18)
E105C (Exp 2/18)
D191C (Exp 2/18)
D192C (Exp 2/18)
D193C (Exp 2/18)
D194C (Exp 2/18)
D195C (Exp 2/18)
D196C (Exp 2/18)
D197C (Exp 2/18)
D198C (Exp 2/18)
D199C (Exp 2/18)
D200C (Exp 2/18)
D201C (Exp 2/18)
E106C (Exp 2/18)
L111C (Exp 5/18)
F005C (Exp 5/18)
F006C (Exp 5/18)
F007C (Exp 5/18)
F008C (Exp 5/18)
H053C (Exp 5/18)
H054C (Exp 5/18)
H055C (Exp 5/18)
H056C (Exp 5/18)
L112C (Exp 6/18)
L113C (Exp 6/18)
L114C (Exp 6/18)
L115C (Exp 6/18)
L116C (Exp 6/18)
Product: Drug Mart Ibuprofen Tablets, USP, 200 mg (50, 100, 500 tablet bottles)
Model:
NDC 53943-291-15
NDC 53943-291-12
NDC 53943-291-14
Lot Numbers:
D167C (Exp 2/18)
E135C (Exp 3/18)
D172C (Exp 2/18)
Product: Ibuprofen Tablets USP 400 mg (100 and 500 tablet bottles)
Model:
NDC 49483-602-01
NDC 49483-602-50
Lot Numbers:
M104C (Exp 9/18)
L016C (Exp 9/18)
H092C (Exp 9/18)
H093C (Exp 9/18)
C128C (Exp 3/18)
C129C (Exp 3/18)
C130C (Exp 3/18)
C132C (Exp 3/18)
HK6011 (Exp 7/18)
Product: Bi-Coastal Pharma Ibuprofen Tablets USP 400 mg (500 tablet bottles)
Model:
NDC 42582-111-18
Lot Numbers:
C128C (Exp 3/18)
C129C (Exp 3/18)
Product: Ibuprofen Tablets USP 600 mg (100 and 500 tablet bottles)
Model:
NDC 49483-603-01
NDC 49483-603-50
Lot Numbers:
C135C (Exp 3/18)
D044C (Exp 3/18)
D045C (Exp 3/18)
D038C (Exp 3/18)
F069C (Exp 4/18)
H095C (Exp 9/18)
C134C (Exp 3/18)
C136C (Exp 3/18)
D039C (Exp 3/18)
D040C (Exp 3/18)
D041C (Exp 3/18)
D042C (Exp 3/18)
D043C (Exp 3/18)
F043C (Exp 4/18)
F067C (Exp 4/18)
F068C (Exp 4/18)
D046C (Exp 4/18)
D047C (Exp 4/18)
H094C (Exp 7/18)
H096C (Exp 9/18)
L026C (Exp 9/18)
H095C (Exp 9/18)
Product: Bi-Coastal Pharma Ibuprofen Tablets USP 600 mg (100 and 500 tablet bottles)
Model:
NDC 42582-112-10
NDC 42582-112-18
Lot Numbers:
D044C (Exp 3/18)
D038C (Exp 3/18)
D043C (Exp 3/18)
C136C (Exp 3/18)
D039C (Exp 3/18)
D040C (Exp 3/18)
D041C (Exp 3/18)
D042C (Exp 3/18)
Product: Drug Mart Ibuprofen Tablets USP 600 mg (100 and 500 tablet bottles)
Model:
NDC 42582-112-01
NDC 42582-112-18
Lot Numbers:
C135C (Exp 3/18)
C134C (Exp 3/18)
Product: Ibuprofen Tablets USP 800 mg (100 and 500 tablet bottles)
Model:
NDC 49483-604-01
NDC 49483-604-50
Lot Numbers (51):
C139C (Exp 2/18)
C140C (Exp 2/18)
F044C (Exp 8/18)
D048C (Exp 2/18)
D049C (Exp 2/18)
D050C (Exp 2/18)
D051C (Exp 2/18)
C142C (Exp 2/18)
C137C (Exp 2/18)
C138C (Exp 2/18)
C141C (Exp 2/18)
D052C (Exp 8/18)
K207C (Exp 8/18)
K208C (Exp 8/18)
K209C (Exp 8/18)
K210C (Exp 8/18)
K211C (Exp 8/18)
K212C (Exp 8/18)
HM6122 (Exp 8/18)
HM6123 (Exp 8/18)
HM6124 (Exp 8/18)
HM6125 (Exp 8/18)
HM6126 (Exp 8/18)
K109C (Exp 8/18)
K110C (Exp 8/18)
K111C (Exp 8/18)
HM6113 (Exp 8/18)
HM6114 (Exp 8/18)
HM6115 (Exp 8/18)
HM6116 (Exp 8/18)
HM6117 (Exp 8/18)
HM6118 (Exp 8/18)
H097C (Exp 8/18)
H098C (Exp 8/18)
H099C (Exp 8/18)
H100C (Exp 8/18)
H101C (Exp 8/18)
K096C (Exp 8/18)
K097C (Exp 8/18)
K098C (Exp 8/18)
K099C (Exp 8/18)
K100C (Exp 8/18)
K101C (Exp 8/18)
K102C (Exp 8/18)
M105C (Exp 9/18)
L017C (Exp 9/18)
L018C (Exp 9/18)
L019C (Exp 9/18)
L020C (Exp 9/18)
L021C (Exp 9/18)
Product: Bi-Coastal Pharma Ibuprofen Tablets USP 800 mg (100 and 500 tablet bottles)
Model:
NDC 42582-113-10
NDC 42582-113-18
Lot Numbers:
C140C (Exp 2/18)
D049C (Exp 2/18)
D050C (Exp 2/18)
D051C (Exp 2/18)
C142C (Exp 2/18)
C137C (Exp 2/18)
C138C (Exp 2/18)
C141C (Exp 2/18)
D073C (Exp 3/18)
D074C (Exp 3/18)
Product: Ibuprofen Caplets USP 200 mg (50, 100, 500, and Bulk bottles)
Model:
NDC 49483-600-05
NDC 49483-600-01
NDC 49483-600-50
NDC 49483-600-00
Lot Numbers:
F066C
Product: Drug Mart Ibuprofen Caplets USP 200 mg (50, 100, and 500 caplet bottles)
Model:
NDC 53943-292-15
NDC 53493-292-12
NDC 53493-292-14
Lot Numbers:
F066C

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79349
Status: Resolved
Manufacturer: Time-Cap Laboratories, Inc.
Sold By: Drug Mart; Food Fair; Bi-Coastal Pharma International; Time-Cap Laboratories
Manufactured In: United States, India
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.