Akorn Recalls Levetiracetam Oral Solution Due to Leaking Bottles
Akorn, Inc. is recalling specific lots of Levetiracetam Oral Solution because customer complaints reported the liquid leaking from the bottles.
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 temporary or medically reversible adverse health consequence. The hazard is a defective container (leaking), which is a packaging issue rather than a direct chemical or biological contamination.
Plain-English summary
Akorn, Inc. is recalling 22,248 bottles of Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL). The product is a prescription-only medication manufactured by Hi-Tech Pharmacal Co., Inc. The recall covers specific lots with expiration dates of 05/2022 and 06/2022.
The recall was initiated due to customer complaints that the oral solution was leaking from the bottles. This is classified as a defective container issue. The affected product was distributed nationwide in the USA and Puerto Rico.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 22,248
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 #: 373859
- 373863
- and 373865
- Exp 05/2022
- 374586
- Exp 06/2022
Distribution
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