CLASS III Drug recall · Reported 19 Jun 2013 · FDA Enforcement Report

Amoxicillin for Oral Suspension, USP 400mg recalled

Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension, USP 400mg, distributed nationwide in the US. The recall was initiated on 26 Apr 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.

NDC0093-2263, 0093-2264, 0093-4160, 0093-4155, 0093-4161, 0093-2267

UPC0300933107051, 0300932264014, 0300934161731, 0300933109055, 0300932267015, 0300932268012

Quantity recalled758,554 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-598-2013
FDA event ID: 65050
Recalling firm: Teva Pharmaceuticals USA, Sellersville, PA
Brand: Amoxicillin
Manufacturer: Teva Pharmaceuticals USA, Inc.
Classification: Class III
Status: Terminated
Recall initiated: 26 Apr 2013
FDA classified: 11 Jun 2013
Reported: 19 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

26 Apr 2013	Recall initiated by company
11 Jun 2013	Classified by FDA	+46 days
19 Jun 2013	Published in enforcement report	+8 days

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

Reason for recall

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Where it was distributed

Nationwide

Questions about this recall

Is Amoxicillin for Oral Suspension, USP 400mg recalled?

Yes. Teva Pharmaceuticals USA recalled Amoxicillin for Oral Suspension, USP 400mg on 26 Apr 2013. The recall is Class III and its status is Terminated. Recall number D-598-2013.

Why was it recalled?

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

Which lots are affected?

a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.

Where was it sold?

Nationwide

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 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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19 Feb 2020Drug	CLASS II	Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg recalledAmoxicillin And Clavulanate Potassium	AuroMedics Pharma	Other	Nationwide
7 Jun 2017Drug	CLASS III	Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg recalledAmoxicillin And Clavulanate Potassium	Sandoz	Potency & Assay	NY, OH