CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Ibuprofen Tablets, USP 600 mg bottle (Capsule Shaped) recalled
Time-Cap Laboratories is recalling Ibuprofen Tablets, USP 600 mg bottle (Capsule Shaped), distributed nationwide in the US. The recall was initiated on 16 Jun 2017 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-1055-2017
- FDA event ID
- 77576
- Recalling firm
- Time-Cap Laboratories, Farmingdale, NY
- Brand
- Ibuprofen
- Manufacturer
- TIME CAP LABORATORIES, INC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2017
- FDA classified
- 3 Aug 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 16 Jun 2017 | Recall initiated by company | |
| 3 Aug 2017 | Classified by FDA | +48 days |
| 9 Aug 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Product as listed by the FDA
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
Where it was distributed
Nationwide U.S.A.
Questions about this recall
Is Ibuprofen Tablets, USP 600 mg bottle (Capsule Shaped) recalled?
Yes. Time-Cap Laboratories recalled Ibuprofen Tablets, USP 600 mg bottle (Capsule Shaped) on 16 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-1055-2017.
Why was it recalled?
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Which lots are affected?
Lot #: HN7003
Where was it sold?
Nationwide U.S.A.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 38| 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 | 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 |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |