The Recall Desk
HighFDA (Drugs)·D-1287-2020·Announced 2020-06-10

Teva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths

Teva Pharmaceuticals USA is recalling 84,209 bottles of 20 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves mixed strengths of a prescription drug, which poses a risk of harm if the wrong dosage is administered, even though specific injuries are not reported in the source text.

Plain-English summary

Teva Pharmaceuticals USA is recalling 84,209 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Amphetamine Salts Product), 20 mg, 100 count bottles. The recall is being conducted because some bottles may contain mixed strengths of the product.

The affected product is identified by Lot # 42617891 with an expiration date of 01/2022. The product was distributed nationwide within the United States and Puerto Rico. The NDC for the specific product description is 0555-0973-02, though other NDCs are listed in the structured data.

Consumers should check their medication for the specific lot number and expiration date. If the product matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Brand
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Affected units
84,209

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 #: 42617891
  • exp. date 01/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA 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 3 products in this recall →

Same brand · DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE