Aurobindo Pharma Recalls Phentermine Hydrochloride Capsules Due to Manufacturing Deviations
Aurobindo Pharma USA Inc. is recalling 2,101 bottles of Phentermine Hydrochloride 15mg capsules because they were manufactured in an area with observed water leakage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (water leakage) without reported illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Aurobindo Pharma USA Inc. is voluntarily recalling 2,101 units of Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles. The product is distributed nationwide within the United States. The specific lot affected is 105180004A, with an expiration date of 03/2020. The product is identified by NDC 13107-105-01.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a processing area where water leakage was observed. This condition may have compromised the quality or safety of the medication.
Consumers who have this specific lot of Phentermine Hydrochloride capsules should stop using the product and contact their healthcare provider or pharmacist for guidance. The recalling firm is Aurobindo Pharma USA Inc.
The recalled product
- Product
- PHENTERMINE (PHENTERMINE HYDROCHLORIDE)
- Brand
- PHENTERMINE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 2,101
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 #: 105180004A
- Exp. Date 03/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Aurobindo Pharma USA 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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