October 2025 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc
D-0151-2026 - Subpotent drug; Clavulanate Potassium component

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on October 13, 2025 for the product Drug. The FDA reported the reason for recall as subpotent drug; clavulanate potassium component. The product was distributed in Distributed in three (3) States: MS, OH, CA. and the recall is currently ongoing.

Recall Number: D-0151-2026

Reason for Recall
Subpotent drug; Clavulanate Potassium component
Initiated
10-13-2025
Reported
11-12-2025
Quantity
4680 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97795
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in three (3) States: MS, OH, CA.
Product Description About Product Description
Full technical description of the product.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.

Batch or Lot Expiration Information

Lot# 100062316, Exp Date: 01/2026