Teva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide
Teva Pharmaceuticals is recalling specific lots of Amoxicillin Oral Suspension because assay results were below specification limits. The affected bottles were distributed nationwide and in Puerto Rico.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a subpotent antibiotic, which poses a risk of treatment failure. No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Amoxicillin for Oral Suspension USP, 125 mg per 5 mL. The recall involves 150 mL and 80 mL bottles that were distributed nationwide in the United States and in Puerto Rico.
The recall was initiated because assay results for the Amoxicillin were below the specification limits, indicating the product is subpotent. The affected lots include specific expiration dates ranging from May 2019 to September 2021.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antibiotic
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 (10)
- 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
Distribution
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