Time-Cap Recalls Ibuprofen Caplets Due to Odor Complaints
Time-Cap Laboratories is recalling specific bottles of Ibuprofen 200 mg caplets due to odor complaints linked to CGMP deficiencies.
What this means for you
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 deficiencies leading to odor complaints, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.
Plain-English summary
Time-Cap Laboratories, Inc. is recalling specific bottles of Ibuprofen Caplets USP 200 mg. The affected products include 50-count, 100-count, and 500-count bottles distributed by Drug Mart, Food Fair, Medina, Ohio. The products were manufactured by Marksans Pharma, Ltd., in Verna, Goa, India.
The recall was initiated due to complaints regarding odor, which are related to Current Good Manufacturing Practice (CGMP) deficiencies. The source text does not specify the number of affected units or report any illnesses or injuries.
Consumers should check their medication for the specific NDC codes and lot number F066C listed in the recall notice. If the product matches the description, consumers should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — OTC Analgesic
- Hazard
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 (1)
- a) F066C b) F066C c) F066C
UPCs (1)
- 0093351027673
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.
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