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Akron Pharma, Inc. recall records

8 reported ongoing

11 records in this archive. Latest source date Dec 12, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Dec 12, 2024FDA drug enforcement

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.

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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 .

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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 7...

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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.

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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 71399-80...

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Dec 12, 2024FDA drug enforcement

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 71399-80...

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

Class IIIReported ongoing

Distribution: Nationwide in the US

Official source

Oct 15, 2024FDA drug enforcement

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 0...

CGMP Deviations

Class IIReported ongoing

Distribution: Nationwide in the US

Official source

Feb 17, 2023FDA drug enforcement

DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIIReported terminated

Distribution: Nationwide within the United States

Official source

Aug 4, 2022FDA drug enforcement

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., F...

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Class IIIReported terminated

Distribution: Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

Official source

Aug 4, 2022FDA drug enforcement

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn ...

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Class IIIReported terminated

Distribution: Product was distributed to 6 distributors/wholesalers who may have further distributed the product.

Official source

Reasons in these listed records

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
CGMP Deviations
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

These examples come from this result page and are not a ranking of every recall reason.

Checking Akron Pharma, Inc.

Is there a recall on akron pharma, inc. right now?

This archive contains 11 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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