Amedra Recalls Dexedrine Capsules Due to Dissolution Test Failures
Amedra Pharmaceuticals is recalling 10,992 bottles of Dexedrine Spansules 15mg due to failed dissolution specifications at the 32-month stability level.
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 remote possibility of serious adverse health consequences or temporary, medically reversible harm. The specific defect is a dissolution failure, which is a quality control issue rather than a direct contamination or acute safety hazard like a structural defect or high-risk pathogen.
Plain-English summary
Amedra Pharmaceuticals LLC is recalling 10,992 bottles of Dexedrine (Dextroamphetamine Sulfate) Spansules Sustained Release Capsules 15mg, 90 count. The product is identified by Lot # 243459 and an expiration date of 01/14. The recall is classified as Class II by the FDA.
The recall was initiated because the product failed dissolution specifications, specifically out-of-specification (OOS) test results for Hour-4 at the 32-month CRT Stability Level. This indicates that the capsules may not release the medication at the intended rate over time.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
- Manufacturer
- Amedra Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,992
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# 243459
- Exp. 01/14
Distribution
Distributed nationwide across the United States.
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