Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0440-2017·Announced 2017-02-01

Teva Recalls Amoxicillin Oral Suspension Due to Low Potency

Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because stability testing revealed the medication was below the required potency standard.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which the rubric associates with moderate severity, particularly when the hazard is a lack of efficacy (subpotency) rather than a direct physical injury risk like contamination or structural failure.

Plain-English summary

Teva Pharmaceuticals USA is recalling 133,601 bottles of Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in 100 mL bottles. The affected product is prescription-only and was distributed in the United States and Puerto Rico. The specific lots involved are 35432507A, 35434914A, 35435798A, and 35437490A, all with an expiration date of 9/19.

The recall was initiated because stability testing produced a low, out-of-specification result for the assay, indicating the medication was subpotent. This means the product may not contain the full amount of active ingredient required to be effective.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product: 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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antibiotic
Hazard: subpotency
Affected units: 133,601

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 (5)

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

Distribution

Distributed in 1 state:

Same manufacturer · Teva Pharmaceuticals USA

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