Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0294-2022·Announced 2021-12-29

Penicillin V Potassium Oral Solution recalled for subpotency

Teva Pharmaceuticals USA is recalling certain lots of Penicillin V Potassium for Oral Solution nationwide because the medication is subpotent—containing less active ingredient than labeled. The recall affects 100 mL and 200 mL bottles distributed nationwide.

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: This is an FDA Class II recall initiated voluntarily by the manufacturer. The source text states the reason for recall is subpotency, and no illnesses or injuries are reported. Under the severity rubric, Class II recalls without reported hospitalization or injury are classified as Moderate (score 2).

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL due to subpotency. The affected products are 100 mL bottles (NDC 00093-4125-73, approximately 86,790 units) and 200 mL bottles (NDC 00093-4125-74, approximately 25,416 units) when mixed.

The specific lots under recall are: for 100 mL bottles—Lot 35446365A (Exp 03/2022), Lot 35447040A (Exp 08/2022), and Lot 35447948B (Exp 03/2023); for 200 mL bottles—Lot 35446318B (Exp 05/2022) and Lot 35447947A (Exp 03/2023). The product was distributed nationwide.

This is a voluntary recall initiated by Teva Pharmaceuticals USA and classified as Class II by the FDA. Patients taking the affected product may not be receiving the full therapeutic dose of penicillin. Consumers should contact their healthcare provider or pharmacist if they have received one of the recalled lots. Do not stop taking penicillin without consulting your doctor, as stopping antibiotic treatment prematurely can be harmful.

The recalled product

Product: Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antibiotic / Oral Solution
Hazard: subpotency
under-potency

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 (8)

a) Lots
35446365A
Exp 03/2022
35447040A
Exp 08/2022 & 35447948B
Exp 03/2023. b) Lots 35446318B
Exp 05/2022 & 35447947A
Exp 03/2023.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · subpotency