Aurobindo Recalls Gabapentin Capsules Due to Manufacturing Water Leakage
Aurobindo Pharma USA Inc. is recalling specific lots of Gabapentin Capsules because they were manufactured in an area with observed water leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential structural or manufacturing defects that compromise product integrity.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 26,625 units of Gabapentin Capsules, USP 100mg, 1,000-count bottles. The affected product is distributed nationwide within the United States and is identified by NDC 65862-198-99. Specific lot numbers and expiration dates are 198180048A (Exp. 04/2021), 198180061A (Exp. 06/2020), and 19819017A1 (Exp. 02/2021).
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 poses a risk to the quality and safety of the medication.
Consumers who have these specific lots of Gabapentin should stop using the medication and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 26,625
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 (6)
- Lot #: 198180048A
- Exp. Date 04/2021
- 198180061A
- Exp. Date 06/2020
- 19819017A1
- Exp. Date 02/2021
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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