Time-Cap Ibuprofen 800mg Recall: Odor Due to CGMP Deviations
Time-Cap Laboratories recalls specific lots of 800 mg Ibuprofen tablets due to odor complaints linked to CGMP deficiencies. Check your bottle's lot number.
Use caution until it’s fixed
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Contact the company
What happened, in plain English
Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 800 mg because of complaints regarding an unusual odor. This issue stems from Current Good Manufacturing Practice (CGMP) deficiencies during production. The recall covers both 100-tablet and 500-tablet prescription bottles distributed nationwide. Read more at govinfonow.com/recall/40935-time-cap-ibuprofen-800mg-recall-odor-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/40935-time-cap-ibuprofen-800mg-recall-odor-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0692-2018
Cite this page
“Time-Cap Ibuprofen 800mg Recall: Odor Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40935-time-cap-ibuprofen-800mg-recall-odor-due-to-cgmp-deviations. Based on FDA recall #D-0692-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0692-2018%22&limit=1).
Why it’s dangerous
The primary hazard is an abnormal odor in the tablets, which indicates potential quality control failures during manufacturing. While the record does not specify chemical contamination or loss of potency, CGMP deviations suggest the product may not meet standard safety and quality specifications.
Who’s affected
Consumers who have purchased the recalled Ibuprofen Tablets USP 800 mg from pharmacies or retailers across the United States. Individuals taking this specific strength of ibuprofen manufactured by Time-Cap Laboratories are most at risk.
How to tell if you have this one
Check your bottle for the National Drug Code (NDC) 49483-604-01 (100 tablets) or NDC 49483-604-50 (500 tablets). Look at the lot number and expiration date on the label. Affected lots include C139C, C140C, F044C (exp 2/18 or 8/18); D048C through D051C, C142C, C137C, C138C, C139C, C141C (exp 2/18); D052C, K207C-K212C, HM6122-HM6126, K109C-K111C, HM6113-HM6118, F044C, H097C-H101C, K096C-K102C (exp 8/18); and M105C, L017C-L022C (exp 9/18).
- Brand
Time-Cap Laboratories- Category
Drug
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots | NDC |
|---|---|---|
| D-0685-2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India; a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18 | 49483-114-50, 49483-114-10, 49483-114-17, 49483-114-73, 49483-601-00, 49483-601-05, 49483-601-01, 49483-601-50, 49483-601-10, 49483-600-05, 49483-600-01, 49483-600-50, 49489-601-10 |
| D-0686-2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256; a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18 | 53943-291-15, 53943-291-12, 53943-291-14 |
| D-0687-2018 | Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India; a) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18, | 49483-602-01, 49483-602-50, 49483-603-03, 49483-603-50, 49483-603-05, 49483-603-01, 49483-604-01, 49483-604-50, 49483-604-05, 49483-604-03 |
| D-0688-2018 | Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India; C128C, C129C, exp 3/18 | — |
| D-0689-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India; a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18 | 49483-602-01, 49483-602-50, 49483-603-03, 49483-603-50, 49483-603-05, 49483-603-01, 49483-604-01, 49483-604-50, 49483-604-05, 49483-604-03 |
| D-0690-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India; a) D044C, D038C, D043C, exp 3/18, b) C136C, exp 3/18, D039C, D040C, D041C, D042C, 3/18 | — |
| D-0691-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256; a) C135C, exp 3/18 b) C134C, exp 3/18 | — |
| D-0692-2018 | 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; a) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M105C, L017C, L018C, L019C, L020C, L021C, L022C, exp 9/18 | 49483-602-01, 49483-602-50, 49483-603-03, 49483-603-50, 49483-603-05, 49483-603-01, 49483-604-01, 49483-604-50, 49483-604-05, 49483-604-03 |
| D-0693-2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India; a) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18 | — |
| D-0694-2018 | 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; a) F066C b) F066C c) F066C | 49483-114-50, 49483-114-10, 49483-114-17, 49483-114-73, 49483-601-00, 49483-601-05, 49483-601-01, 49483-601-50, 49483-601-10, 49483-600-05, 49483-600-01, 49483-600-50, 49483-600-00 |
| D-0695-2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India; a) F066C b) F066C c) F066C | 53943-292-15, 53943-292-12, 53943-292-14, 53493-292-12, 53493-292-14 |
What to do — step by step
Check Your Bottle
Verify if your Ibuprofen Tablets USP 800 mg match the NDC and lot numbers listed in the recall record.
Stop Using Affected Product
If you have one of the recalled lots, discontinue use due to the reported odor and manufacturing deficiencies.
Contact Manufacturer
Reach out to Time-Cap Laboratories, Inc. for further instructions on returns or refunds, as specific remedy details are not provided in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0692-2018 (January 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0692-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.