Multi-event December 2024 FDA Recall Drug by Akron Pharma, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Akron Pharma, Inc. on December 12, 2024 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0198-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
456 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# Lot: KDC0124002B Exp 09/30/2026
Recall Number: D-0196-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
1232 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# s: KDT0224001B, Exp 08/31/2026; KDT0224002B, Exp 09/30/2026.
Recall Number: D-0197-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
7198 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# Lot: KDC0124001A Exp 09/30/2026.
Recall Number: D-0195-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
14825 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Batch or Lot Expiration Information
Lot# s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026
Recall Number: D-0199-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
324 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# Lot: KDC0224001B Exp 09/30/2026
Recall Number: D-0194-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
6429 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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 .
Batch or Lot Expiration Information
Lot# : KDT0124001, Exp 08/31/2026
Recall Number: D-0193-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
12-12-2024
01-22-2025
768 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# Lot: KDT0224002A, Exp 09/30/2026
