The Recall Desk
HighFDA (Drugs)·D-0151-2026·Announced 2025-11-12

[pending] Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when

Pending LLM rewrite. Source: FDA_DRUG D-0151-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Subpotent drug; Clavulanate Potassium component

The recalled product

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 0093-22
Manufacturer
Teva Pharmaceuticals USA, Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 100062316
  • Exp Date: 01/2026

Distribution

Distributed in 3 states:

  • CA
  • MS
  • OH