Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules
Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a quality defect (empty capsules) that may reduce efficacy but does not pose an immediate safety risk.
Plain-English summary
Aurobindo Pharma USA Inc is recalling Dicyclomine Hydrochloride Capsules, USP, 10mg, NDC 59651-719-99, distributed nationwide in 1,000-bottle units. The recall is due to reports of empty capsules found in the product.
The recalled product was distributed to the U.S. market with 6,408 bottles released. The affected units are identified by Batch # DMC125018A and Exp Date: 07/2027.
Healthcare providers and consumers who have the affected product should stop using it and return it to the place of purchase. Consumers should contact their pharmacy or healthcare provider if they have questions about the recall.
The recall was initiated due to reports of empty capsules, which may affect the efficacy of the medication. No other lots or strengths are affected by this recall.
The recalled product
- Product
- DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
- Brand
- DICYCLOMINE HYDROCHLORIDE
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Capsules
- Affected units
- 6,408
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)
- Batch # DMC125018A
- Exp Date: 07/2027.
UPCs (1)
- 0359651719015
Distribution
Distributed nationwide across the United States.
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