ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
ANI Pharmaceuticals recalls 25mg amphetamine capsules with incorrect expiration date (labeled 24 months instead of 18 months). This affects certain prescription bottles manufactured in 2021. Consumers should check their product labels and contact the manufacturer for details.
Lower-risk recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Contact the company & request your remedy
What happened, in plain English
ANI Pharmaceuticals is recalling 25mg amphetamine capsules that were labeled with a 24-month expiration date instead of the correct 16-month expiration date. This labeling error means the product could expire earlier than intended, potentially leading to ineffective medication. Read more at govinfonow.com/recall/36715-ani-pharmaceuticals-recalls-25mg-amphetamine-capsules-due-to-incorrect-expiration.
Source Summary by GovInfoNow · govinfonow.com/recall/36715-ani-pharmaceuticals-recalls-25mg-amphetamine-capsules-due-to-incorrect-expiration · Updated October 4, 2026 · FDA enforcement record: FDA #D-0047-2021
Cite this page
“ANI Pharmaceuticals recalls 25mg amphetamine capsules due to incorrect expiration date.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36715-ani-pharmaceuticals-recalls-25mg-amphetamine-capsules-due-to-incorrect-expiration. Based on FDA recall #D-0047-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0047-2021%22&limit=1).
Why it’s dangerous
The capsules were labeled with a 24-month expiration date instead of the correct 18-month expiration date. This means the medication may become ineffective before the intended expiration date, potentially leading to treatment failure.
Who’s affected
Prescription holders of the 25mg amphetamine capsules with the specific NDC number 43975-281-10. People who take these medications for ADHD or other conditions are most at risk.
How to tell if you have this one
Check for the product name 'Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate' on the label. Look for the NDC number 43975-281-10 and the expiration date labeled as January 2022.
- Brand
ANI Pharmaceuticals- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Distributed Nationwide in the USA- NDC
43975-277-10, 43975-278-10, 43975-279-10, 43975-280-10, 43975-282-10, 43975-281-10
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0043-2021 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10; Lot: 19S07 Exp. Sept. 2021 | 408 bottles |
| D-0044-2021 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10; Lot: 19S10 Exp. Sept. 2021, 19S11 Exp. Oct. 2021 | 13536 bottles |
| D-0045-2021 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10; Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022 | 13248 bottles |
| D-0046-2021 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10; Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022 | 24972 bottles |
| D-0047-2021 | 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; Lot: 19T16 Exp. Jan. 2022 | 6780 bottles |
| D-0048-2021 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10; Lot: 19T17 Exp. Dec. 2021, 19T18, 19T19, Exp. Jan. 2022; 20D05 Exp. Apr. 2022; 20D21, Exp. May 2022 | 34968 bottles |
What to do — step by step
Check Product Label
Look for the NDC number 43975-281-10 and expiration date labeled as January 2022 on the capsule packaging.
Questions people ask
Why is this product being recalled?
The product was labeled with a 24-month expiration date instead of the correct 18-month expiration date.
How can I tell if I have the recalled product?
Check for the NDC number 43975-281-10 and expiration date labeled as January 2022 on the capsule packaging.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact ANI Pharmaceuticals for further instructions.
Contact ANI Pharmaceuticals
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0047-2021 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0047-2021 from ANI Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0047-2021 (October 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0047-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.