--- title: "Akron Pharma, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Akron Pharma, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/akron-pharma-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 12, 2024 FDA 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.](https://isitonrecall.com/recall/fda-drug-d-0193-2025-acetaminophen-extra-strength-500-mg-100-tablets-per-bottle-akron-pharma-inc-373-rt-us-46-w-building/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W B...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0193-2025%22) Dec 12, 2024 FDA 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 .](https://isitonrecall.com/recall/fda-drug-d-0194-2025-acetaminophen-regular-strength-325-mg-100-tablets-per-bottle-akron-pharma-inc-373-rt-us-46-w-buildin/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0194-2025%22) Dec 12, 2024 FDA drug enforcement ### [Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.](https://isitonrecall.com/recall/fda-drug-d-0195-2025-acetaminophen-325-mg-tablets-100-tablets-per-bottle-akron-pharma-manufactured-for-akron-pharma-inc-f/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Phar...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0195-2025%22) Dec 12, 2024 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-0196-2025-acetaminophen-extra-strength-500-mg-1000-tablets-per-bottle-akron-pharma-manufactured-for-akron-phar/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0196-2025%22) Dec 12, 2024 FDA 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.](https://isitonrecall.com/recall/fda-drug-d-0197-2025-diphenhydramine-hcl-25-mg-100-capsules-per-bottle-akron-pharma-manufactured-for-akron-pharma-inc-373/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0197-2025%22) Dec 12, 2024 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-0198-2025-diphenhydramine-hcl-25-mg-1000-capsules-per-bottle-akron-pharma-manufactured-for-akron-pharma-inc-37/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0198-2025%22) Dec 12, 2024 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-0199-2025-diphenhydramine-hcl-50-mg-1000-capsules-per-bottle-akron-pharma-manufactured-for-akron-pharma-inc-37/) Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Reported ongoing Distribution: Nationwide in the US [Official source for Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0199-2025%22) Oct 15, 2024 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-0025-2025-onelax-docusate-sodium-liquid-docusate-sodium-50-mg-5-ml-stool-softener-laxative-16-fl-oz-473-ml-bot/) CGMP Deviations Class II Reported ongoing Distribution: Nationwide in the US [Official source for OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0025-2025%22) Feb 17, 2023 FDA drug enforcement ### [DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1](https://isitonrecall.com/recall/fda-drug-d-0454-2023-dibucaine-1-hemorrhoidal-ointment-1-oz-28-gm-manufactured-for-akron-pharma-inc-fairfield-nj-07004-nd/) Labeling: Incorrect or Missing Lot and/or Exp Date Class III Reported terminated Distribution: Nationwide within the United States [Official source for DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0454-2023%22) Aug 4, 2022 FDA 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...](https://isitonrecall.com/recall/fda-drug-d-1352-2022-acetaminophen-325-mg-tablets-packaged-in-a-100-count-bottle-ndc-71399-8024-01-b-1000-count-bottle-nd/) Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. Class III Reported terminated Distribution: Product was distributed to 6 distributors/wholesalers who may have further distributed the product. [Official source for Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1352-2022%22) Aug 4, 2022 FDA 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 ...](https://isitonrecall.com/recall/fda-drug-d-1353-2022-acetaminophen-500-mg-tablet-extra-strength-packaged-in-a-100-count-bottle-ndc-71399-8022-01-b-1000-c/) Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. Class III Reported terminated Distribution: Product was distributed to 6 distributors/wholesalers who may have further distributed the product. [Official source for Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01),...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1353-2022%22) ## 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](https://isitonrecall.com/guides/read-lot-codes/) 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search Akron Pharma, Inc.](https://isitonrecall.com/check/?q=Akron%20Pharma%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)