Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
Impax Laboratories is recalling specific lots of Dextroamphetamine Sulfate Tablets because they failed impurity and degradation specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks.
Plain-English summary
Impax Laboratories, Inc. is recalling 18,936 bottles of Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottles. The affected products are identified by Lot # 112565 (Exp 03/17) and Lot # 113458 (Exp 08/17). The recall was initiated because the products failed impurities and degradation specifications.
The recalled medication is distributed nationwide. The product is manufactured and distributed by CorePharma, LLC, located in Middlesex, NJ, and carries the NDC 64720-215-10. It is a prescription-only medication.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
- Manufacturer
- Impax Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 18,936
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 (4)
- Lot #: 112565
- Exp 03/17
- 113458
- Exp 08/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Impax Laboratories, 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Impax Laboratories, Inc.
See all →- SevereImpax Recalls Lamotrigine Tablets Due to Labeling Mixup
FDA (Drugs) · 2016-12-28
- SevereImpax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2016-04-27
- LowImpax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20
- LowImpax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateActavis Recalls Dextroamphetamine Tablets for Impurity Failures
FDA (Drugs) · 2016-04-13
- ModerateActavis Recalls Dextroamphetamine Tablets Due to Impurity Failures
FDA (Drugs) · 2016-04-13
- SevereActavis Recalls Amphetamine Tablets Due to Impurity Failures
FDA (Drugs) · 2016-04-13
- SevereTeva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures
FDA (Drugs) · 2014-07-02
- ModerateLupin Recalls Morphine Sulfate Extended-Release Tablets for Impurity Failures
FDA (Drugs) · 2019-05-01
- SevereSun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures
FDA (Drugs) · 2020-01-22