Exact FDA event identifier

Event 86584

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 09, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: ANI Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 6

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

D-0043-2021

Recall number: D-0043-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 408 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

Lot: 19S07 Exp. Sept. 2021

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 6

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

D-0044-2021

Recall number: D-0044-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 13536 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

Lot: 19S10 Exp. Sept. 2021, 19S11 Exp. Oct. 2021

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 6

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

D-0045-2021

Recall number: D-0045-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 13248 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

Lot: 19T14 Exp. Dec. 2021, 20D06 Exp. Apr. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 4 of 6

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

D-0046-2021

Recall number: D-0046-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 24972 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 5 of 6

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

D-0047-2021

Recall number: D-0047-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 6780 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

Lot: 19T16 Exp. Jan. 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 6 of 6

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

D-0048-2021

Recall number: D-0048-2021
Initiated: October 09, 2020
Classification: Class III
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 34968 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Code information

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

Distribution pattern

Distributed Nationwide in the USA