Teva Recalls Amoxicillin-Clavulanate Antibiotic Tablets Due to Subpotency
Teva Pharmaceuticals is recalling 34,448 bottles of Amoxicillin and Clavulanate Potassium Tablets USP (Chewable 400mg/57mg) distributed nationwide due to subpotency. The recall is voluntary and initiated by the firm.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II drug recall for subpotent Amoxicillin-Clavulanate tablets. While no illnesses or injuries are reported in the source, subpotent antibiotics pose a risk of treatment failure in patients depending on this medication's therapeutic efficacy.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg formulation, sold in 20-count bottles. The recall affects 34,448 bottles that were distributed nationwide throughout the United States.
The tablets have been found to be subpotent, meaning they contain less active pharmaceutical ingredient than intended. Subpotent antibiotics may not adequately treat bacterial infections as intended.
The affected lot numbers are 100047634 (expiration April 2025) and 35449379A (expiration July 2024). Patients taking this medication should consult their healthcare provider. The firm voluntarily initiated this recall on June 4, 2024.
The recalled product
- Product
- Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 34,448
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 (3)
- Lot #: 100047634 Exp. Date 4/2025
- 35449379A
- Exp. Date 7/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA, Inc
See all →- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.3 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
Similar recalls
- HighAmoxicillin clavulanate oral suspension recalled as subpotent in the clavulanate component
FDA (Drugs) · 2025-11-12
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Low Potency
FDA (Drugs) · 2017-02-01
- HighTeva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide
FDA (Drugs) · 2019-04-24
- LowSandoz Recalls Subpotent Amoxicillin and Clavulanate Potassium Tablets
FDA (Drugs) · 2017-06-07
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Potency Issues
FDA (Drugs) · 2016-08-31
- ModerateTeva Recalls Clozapine Tablets Due to Potential Broken Tablets
FDA (Drugs) · 2017-12-06