The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0048-2021·Announced 2020-10-28

ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.

Plain-English summary

ANI Pharmaceuticals, Inc. is recalling 34,968 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 30 mg, 100-count. The product is manufactured for Amerigen Pharmaceuticals, Inc. and is distributed nationwide in the USA.

The recall was initiated due to a labeling error where the product was dated with a 24-month expiration date instead of the correct 18-month expiration date. The affected lots include 19T17, 19T18, 19T19, 20D05, and 20D21, with expiration dates ranging from December 2021 to May 2022.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Brand
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
34,968

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 (7)

  • Lot: 19T17 Exp. Dec. 2021
  • 19T18
  • 19T19
  • Exp. Jan. 2022
  • 20D05 Exp. Apr. 2022
  • 20D21
  • Exp. May 2022

UPCs (6)

  • 0343975282102
  • 0343975281105
  • 0343975278105
  • 0343975280108
  • 0343975277108
  • 0343975279102

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by ANI Pharmaceuticals, 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 6 products in this recall →

Related recalls

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

Same manufacturer · ANI Pharmaceuticals, Inc.

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Same hazard · mis labeling

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