Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen 800 mg tablets due to odor complaints linked to CGMP deficiencies.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations related to odor complaints without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 800 mg. The recall affects 100-tablet and 500-tablet bottles (NDC 49483-604-01 and NDC 49483-604-50) distributed nationwide. The products were manufactured by Marksans Pharma, Ltd. in India for Time-Cap Laboratories in Farmingdale, NY.
The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The agency has classified this as a Class II recall.
Consumers should check their medication for the specific lot codes and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) C139C
- C140C
- exp 2/18
- F044C
- exp 8/18
- b) D048C
- D049C
- D050C
- D051C
- C142C
- C137C
- C138C
- C139C
- C141C
- D052C
- K207C
- K208C
- K209C
- K210C
- K211C
UPCs (6)
- 0349483604504
- 0349483604016
- 0349483602012
- 0349483602500
- 0349483603507
- 0349483603019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Time-Cap Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same brand · IBUPROFEN
- HighChildren's ibuprofen suspension recalled over gel-like mass and black particles
FDA (Drugs) · 2026-03-25
- HighIbuprofen tablets recalled nationwide due to temperature abuse during manufacturing
FDA (Drugs) · 2022-06-15
- ModerateCardinal Health Recalls Ibuprofen Oral Suspension Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateTaro Recalls Children's Ibuprofen Oral Suspension Due to Foreign Plastic Particles
FDA (Drugs) · 2019-11-06
- ModerateTaro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles
FDA (Drugs) · 2019-11-06
Same manufacturer · Time-Cap Laboratories, Inc.
See all →- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
- ModerateIbuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Caplets Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Caplets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateIbuprofen Tablets Recalled for Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-01-31
- ModerateIbuprofen Tablets Recalled by FDA Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-01-31
- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Foreign Capsule Presence
FDA (Drugs) · 2017-08-09
- ModerateIbuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-01-31
- ModerateMarksans Pharma Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-01-31
- HighPrescription Ibuprofen Recalled Due to Failed Impurity Specifications
FDA (Drugs) · 2024-09-04