Time-Cap Recalls Ibuprofen Tablets Due to Foreign Capsule Presence
Time-Cap Laboratories is recalling 1,980 bottles of 600 mg ibuprofen tablets because some bottles contained 800 mg tablets.
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 the hazard involves a dosage discrepancy (foreign tablets of a different strength) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Time-Cap Laboratories, Inc. is recalling 1,980 bottles of Ibuprofen Tablets USP, 600 mg, 500-count bottles (NDC 49483-603-50). The recall was initiated because some of the 600 mg bottles were found to contain Ibuprofen Tablets USP 800 mg.
The affected product is a prescription-only medication manufactured by Marksans Pharma Ltd. in India for Time-Cap Laboratories, Inc. The specific lot number is HN7003. The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,980
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)
- Lot #: HN7003
UPCs (6)
- 0349483604504
- 0349483604016
- 0349483602012
- 0349483602500
- 0349483603507
- 0349483603019
Distribution
Distributed nationwide across the United States.
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