The Recall Desk
ModerateFDA (Drugs)·D-0813-2016·Announced 2016-04-13

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.

What this means for you

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, M
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 →

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