CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report

Amoxicillin for Oral Suspension USP, 125 mg recalled

Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension USP, 125 mg per, distributed nationwide in the US. The recall was initiated on 12 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021

Quantity recalled171,488 150 mL and 80 mL bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1205-2019
FDA event ID: 82619
Recalling firm: Teva Pharmaceuticals USA, North Wales, PA
Classification: Class II
Status: Terminated
Recall initiated: 12 Apr 2019
FDA classified: 18 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

12 Apr 2019	Recall initiated by company
18 Apr 2019	Classified by FDA	+6 days
24 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Product: assay results for Amoxicillin were below the specification limits.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent Product: assay results for Amoxicillin were below the specification limits.

Which lots are affected?

Lots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021

Where was it sold?

Nationwide in the USA and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Amoxicillin For recalls

All 4

Reported	Class	Recall	Company	Reason	Where
1 Feb 2017Drug	CLASS II	Amoxicillin for Oral Suspension USP, 125 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	PR
28 Sep 2016Drug	CLASS III	Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg recalled	West-Ward Pharmaceuticals	Other	Nationwide
10 Apr 2013Drug	CLASS II	Amoxicillin for Oral Suspension, 125mg/, a) recalled	Dr Reddys Laboratories Tennessee	Mold	Nationwide