Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 28, 2020
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
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ani Pharmaceuticals, Inc. recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat… - a low-severity action.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat… was recalled by Ani Pharmaceuticals, Inc. in October 28, 2020. Reason: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.. Check the official notice for the remedy. Verify recall #D-0045-2021 with the FDA Drug before acting.
The recall
Ani Pharmaceuticals, Inc. issued this low-severity FDA Drug recall-Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months..
- Low
- severity level
- Class III
- classification
- October 28, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0045-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0045-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on October 9, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Ani Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Baudette, MN. Federal records list the affected scope as 13248 bottles.
The documented reason for this recall is: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13248 bottles
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0045-2021 |
| Date reported | October 28, 2020 |
| Date initiated | October 9, 2020 |
| Recalling firm | Ani Pharmaceuticals, Inc. |
| Firm location | Baudette, MN |
| Affected scope | 13248 bottles |
| Distribution | Distributed Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0045-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ani Pharmaceuticals, Inc.. Units affected: 13248 bottles.
Why was this product recalled? ▼
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 28, 2020. Severity: Low. Recall number: D-0045-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0045-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 28, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.