ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 13,248 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling 13,248 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 15 mg. The product is a prescription-only medication manufactured for Amerigen Pharmaceuticals, Inc. The recall involves specific lots with expiration dates of December 2021 and April 2022.
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. This discrepancy affects the accuracy of the product's shelf life information.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific NDC codes and lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
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
- 13,248
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: 19T14 Exp. Dec. 2021
- 20D06 Exp. Apr. 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
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