Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications
Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.
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 where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality control failure (unknown impurity) rather than a known high-risk pathogen or structural defect.
Plain-English summary
Akorn, Inc. is recalling Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only. The recall involves 8,183 unit dose cups distributed nationwide in the United States.
The recall was initiated because the product failed impurities/degradation specifications. Specifically, an out-of-specification unknown impurity was observed during 6-month stability testing. The affected lots are 369409 (Exp. 05/2021), 372393 (Exp. 01/2022), and 373112 (Exp. 04/2022).
This product is for institutional use only. Healthcare facilities and pharmacies should stop using the affected product and contact Akorn, Inc. for further instructions.
The recalled product
- Product
- Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 8,183
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 369409
- Exp. Date 05/2021
- Lot 372393
- Exp. Date 01/2022
- Lot 373112
- Exp. Date 04/2022
Distribution
Distributed nationwide across the United States.
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