RecallRadar

FDA Drug recall D-0196-2025

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E,…

On 2025-01-22 the FDA classified a Class III recall of Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E,… by Akron Pharma, citing labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0196-2025
ClassificationClass III
Statusongoing
Initiated2024-12-12
Published2025-01-22
Last updated2026-09-13 11:52 UTC
CompanyAkron Pharma
DistributionUS

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0196-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.