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.
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 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
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Same manufacturer · Time-Cap Laboratories, Inc.
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