Use caution Drug recall · FDA · Published June 18, 2013

Teva Recalls Amoxicillin Oral Suspension Due to Discoloration

Teva Pharmaceuticals recalls specific lots of Amoxicillin for Oral Suspension due to orange to brown discoloration on inner foil seals.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-803-2013Drug Teva Pharmaceuticals ›

Use caution until it’s fixed

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc.650 Cathill Rd · Sellersville, PA 18960-1512

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA is recalling specific lots of Amoxicillin for Oral Suspension, USP 200 mg/5 mL because the powder on the inner foil seal has turned orange to brown. This recall expands upon a previous action (RES 65050). The affected products were distributed nationwide and include both 75 mL and 100 mL bottles. Read more at govinfonow.com/recall/47445-teva-pharmaceuticals-usa-inc-recalls-amoxicillin-for-oral-suspension-usp.

Source Summary by GovInfoNow · govinfonow.com/recall/47445-teva-pharmaceuticals-usa-inc-recalls-amoxicillin-for-oral-suspension-usp · Updated October 13, 2026 · FDA enforcement record: FDA #D-803-2013

Cite this page

“Teva Recalls Amoxicillin Oral Suspension Due to Discoloration.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47445-teva-pharmaceuticals-usa-inc-recalls-amoxicillin-for-oral-suspension-usp. Based on FDA recall #D-803-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-803-2013%22&limit=1).

The FDA announced on June 18, 2013, that Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin for Oral Suspension due to orange to brown discoloration on inner foil seals. The agency classified the recall as Class III.

How to tell if you have it

Brand: Teva Pharmaceuticals
Product: Amoxicillin for Oral Suspension, USP 200 mg/5 mL
75 mL bottle NDC 0093-4160-78
100 mL bottle NDC 0093-4160-73
Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14

The hazard

The recall addresses orange to brown discolored Amoxicillin powder found on the inner foil seal of the bottles. This action expands upon recall RES 65050.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Recent Teva recalls include traZODone 50mg tablets with a foreign tablets risk (August 24, 2026), Octreotide Acetate 30mg Kit with a sterility risk (April 24, 2026), and Claravis 10mg due to impurity issues (April 6, 2026). Other recent recalls of similar products include Blossom Pharmaceuticals Zinc Oxide Ointment Recall (October 31, 2025), Dabur Med Pride Bacitracin Zinc Ointment Recall (June 2, 2026), and Rising Pharma Recalls Temozolomide 5mg Capsules Due to Impurity Issues (March 3, 2026).

How to tell if you have this one

Check if you have Amoxicillin for Oral Suspension, USP 200 mg/5 mL manufactured by Teva Canada Limited. Look for NDC numbers 0093-4160-78 (75 mL bottle) or 0093-4160-73 (100 mL bottle). Verify the lot numbers: a) 35426557A, 35426558A or b) 35426554A, 35426555A, 35426556A, all with an expiration date of 08/14.

Brand
Teva Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check your medication
Verify if your Amoxicillin bottle matches the NDC numbers and lot numbers listed in the recall details.
Contact your pharmacist
If you have one of the recalled lots, contact your pharmacy or healthcare provider for instructions on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

Jun 18, 2013Firm started the recall
Jul 17, 2013FDA classified it Class III
Jul 24, 2013Published in FDA’s Enforcement Report
Dec 24, 2013FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Teva Pharmaceuticals recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/47445-teva-pharmaceuticals-usa-inc-recalls-amoxicillin-for-oral-suspension-usp">Teva Recalls Amoxicillin Oral Suspension Due to Discoloration (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-803-2013 (June 18, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-803-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.