Hetero Labs Recalls Indomethacin Capsules Due to Deformed or Clumped Units
Hetero Labs is recalling 18,288 bottles of Indomethacin 50 mg capsules due to customer complaints of deformed, clumped, or stuck together capsules.
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, but the source text cites only cosmetic/physical defects (deformed, clumped, melted) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hetero Labs, Ltd. - Unit III is recalling 18,288 bottles of Indomethacin Capsules, USP, 50 mg. The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. and distributed nationwide in the USA. The specific lot affected is E180315, with an expiration date of 12/19.
The recall was initiated due to customer complaints regarding failed tablet/capsule specifications. Specifically, users reported that the capsules were deformed, clumped, misshaped, melted, or stuck together. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall number for this action is D-1019-2018.
The recalled product
- Product
- INDOMETHACIN (INDOMETHACIN)
- Brand
- INDOMETHACIN
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Prescription Drug
- Affected units
- 18,288
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 (2)
- Lot #: E180315
- Exp 12/19
UPCs (2)
- 0331722543019
- 0331722542012
Distribution
Distributed nationwide across the United States.
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