CLASS II Drug recall · Reported 2 May 2018 · FDA Enforcement Report
Ibuprofen Tablets USP 600 mg, a) recalled by Time-Cap Laboratories
Time-Cap Laboratories is recalling Ibuprofen Tablets USP 600 mg, a) (, distributed nationwide in the US. The recall was initiated on 11 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0689-2018
- FDA event ID
- 79349
- Recalling firm
- Time-Cap Laboratories, Farmingdale, NY
- Brand
- Ibuprofen
- Manufacturer
- TIME CAP LABORATORIES, INC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2018
- FDA classified
- 22 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 11 Jan 2018 | Recall initiated by company | |
| 22 Apr 2018 | Classified by FDA | +101 days |
| 2 May 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Which lots are affected?
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
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 79349This product is part of a recall event; the main page for the event is Ibuprofen Tablets USP 800 mg, a) recalled by Time-Cap Laboratories.
More recalls from Time-Cap Laboratories
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ibuprofen Caplets USP 200 mg, a) 50 caplets recalledIbuprofen | Time-Cap Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP, 200 mg, a) recalled by Time-Cap LaboratoriesIbuprofen | Time-Cap Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets USP 800 mg, a) recalled by Time-Cap Laboratories | Time-Cap Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets USP 400 mg bottles recalled by Time-Cap Laboratories | Time-Cap Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Caplets USP 200 mg, a) 50 caplets recalledIbuprofen | Time-Cap Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
Other Ibuprofen recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |