CLASS III Drug recall · Reported 28 Oct 2020 · FDA Enforcement Report
Dextroamphetamine Saccharate recalled by ANI Pharmaceuticals
ANI Pharmaceuticals is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine, distributed nationwide in the US. The recall was initiated on 9 Oct 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0047-2021
- FDA event ID
- 86584
- Recalling firm
- ANI Pharmaceuticals, Baudette, MN
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Oct 2020
- FDA classified
- 21 Oct 2020
- Reported
- 28 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 9 Oct 2020 | Recall initiated by company | |
| 21 Oct 2020 | Classified by FDA | +12 days |
| 28 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Product as listed by the FDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine recalled?
Yes. ANI Pharmaceuticals recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine on 9 Oct 2020. The recall is Class III and its status is Terminated. Recall number D-0047-2021.
Why was it recalled?
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Which lots are affected?
Lot: 19T16 Exp. Jan. 2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ANI Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride | ANI Pharmaceuticals | Other | Nationwide |
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| Drug | CLASS II | Alprazolam Tablets, USP 0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
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Other Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |