Teva Pharmaceuticals Amoxicillin for Oral Suspension Recall

Why it was recalled

Subpotency: due to a low, out of specification test result for assay during stability testing.

Product description

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Lot numbers, UPCs & expiration codes

Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19

Where it was sold

United States and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0440-2017
Classification: Class II
Status: Terminated
Recall initiated: Dec 21, 2016
FDA report date: Feb 1, 2017
Quantity: 133,601 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0440-2017, exactly as published.

Show all FDA fields

City: North Wales
State: PA
Status: Terminated
Country: United States
Event ID: 76038
Address: 1090 Horsham Rd
Code information: Lot # 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19
Postal code: 19454-1505
Report date: Feb 1, 2017
Product type: Drugs
Recall number: D-0440-2017
Classification: Class II
Recalling firm: Teva Pharmaceuticals USA
Product quantity: 133,601 bottles
Termination date: Feb 6, 2018
Reason for recall: Subpotency: due to a low, out of specification test result for assay during stability testing.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Distribution pattern: United States and Puerto Rico
Recall initiation date: Dec 21, 2016
Initial firm notification: Letter
Center classification date: Jan 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0440-2017, published Feb 1, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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