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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95944

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

Open FDA event record

Event summary

Timeline bucket
December 12, 2024
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Akron Pharma, 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

Complete imported group

Every recalled product in this event

7 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 7

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

D-0193-2025
Recall number
D-0193-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
768 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot: KDT0224002A, Exp 09/30/2026

Distribution pattern

Nationwide in the US

drug · product 2 of 7

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

D-0194-2025
Recall number
D-0194-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
6429 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot #: KDT0124001, Exp 08/31/2026

Distribution pattern

Nationwide in the US

drug · product 3 of 7

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

D-0195-2025
Recall number
D-0195-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
14825 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026

Distribution pattern

Nationwide in the US

drug · product 4 of 7

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

D-0196-2025
Recall number
D-0196-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
1232 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot #s: KDT0224001B, Exp 08/31/2026; KDT0224002B, Exp 09/30/2026.

Distribution pattern

Nationwide in the US

drug · product 5 of 7

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

D-0197-2025
Recall number
D-0197-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
7198 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot: KDC0124001A Exp 09/30/2026.

Distribution pattern

Nationwide in the US

drug · product 6 of 7

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

D-0198-2025
Recall number
D-0198-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
456 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot: KDC0124002B Exp 09/30/2026

Distribution pattern

Nationwide in the US

drug · product 7 of 7

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

D-0199-2025
Recall number
D-0199-2025
Initiated
December 12, 2024
Classification
Class III
Status
Ongoing
Recalling firm
Akron Pharma, Inc.
Quantity
324 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information

Lot: KDC0224001B Exp 09/30/2026

Distribution pattern

Nationwide in the US