Actavis Recalls Dextroamphetamine Tablets for Impurity Failures
Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles 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 reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is limited to impurity failures without specified severe clinical outcomes.
Plain-English summary
Actavis Elizabeth LLC is recalling 114,388 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg. The product is distributed by Actavis, Inc. and is available by prescription only. The recall involves ten specific lot numbers with expiration dates ranging from March 2016 to April 2017.
The recall was initiated because the tablets failed to meet impurities/degradation specifications. The source text indicates the product was out of specification for impurities but does not specify the nature of the impurities or the exact mechanism of failure.
The affected product was distributed nationwide in the United States. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 114,388
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 (17)
- Lot #: 2172#141
- Expiry: 3/16
- Lot #: 4217K141
- Lot #: 0420A151
- Expiry: 7/16
- Lot #: 0421A151
- Lot #: 0854B151
- Expiry: 10/16
- Lot #: 1329C151
- Lot #: 2692F151
- Expiry
- 2/17
- Lot #: 3202G151
- Expiry: 3/17
- Lot #: 3796J151
- Lot #: 3797J151
- Expiry: 4/17.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Actavis Elizabeth LLC 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 4 products in this recall →Related recalls
Same manufacturer · Actavis Elizabeth LLC
See all →- ModerateActavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets
FDA (Drugs) · 2016-11-30
- SevereActavis Recalls Dextroamphetamine Tablets Due to 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
- ModerateActavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
FDA (Drugs) · 2015-03-11
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 Amphetamine Extended-Release Capsules for Dissolution Failure
FDA (Drugs) · 2013-03-13
- ModerateActavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
FDA (Drugs) · 2016-08-03
- SevereImpax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2016-04-27
- ModerateActavis Recalls Alprazolam Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-03-12
- SevereTeva Recalls Dextroamphetamine Tablets Due to Unknown Impurities
FDA (Drugs) · 2014-11-05
- ModerateAmphetamine extended-release capsules 15 mg recalled after impurity testing failure
FDA (Drugs) · 2025-10-01