Medications & Supplements/Prescription Drugs

Teva Penicillin V Potassium Oral Solution Recalled for Subpotency

Agency Publication Date: December 23, 2021

Summary

Teva Pharmaceuticals USA is recalling Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL, in 100 mL and 200 mL bottle sizes. The recall affects approximately 86,790 bottles of the 100 mL size and 25,416 bottles of the 200 mL size. This medication is being recalled because testing revealed it was subpotent, meaning it may not contain the full strength of the antibiotic required to treat infections effectively. No injuries or incidents have been reported to date.

Risk

Subpotent antibiotics may fail to properly treat bacterial infections, which could lead to prolonged illness or worsening of the patient's condition. There are no reported injuries, but the lack of efficacy poses a moderate health risk.

What You Should Do

This recall involves Teva Penicillin V Potassium for Oral Solution (125 mg per 5 mL) packaged in 100 mL (NDC 00093-4125-73) and 200 mL (NDC 00093-4125-74) bottles.
Identify the lot number and expiration date on your medication bottle. For the 100 mL bottles, look for lots 35446365A (Exp 03/2022), 35447040A (Exp 08/2022), or 35447948B (Exp 03/2023). For the 200 mL bottles, look for lots 35446318B (Exp 05/2022) or 35447947A (Exp 03/2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Penicillin V Potassium for Oral Solution, USP (100 mL)by Teva

Variants: 125 mg (200,000 U) per 5 mL, 100 mL, Rx Only

Lot Numbers:

35446365A (Exp 03/2022)

35447040A (Exp 08/2022)

35447948B (Exp 03/2023)

NDC:

00093-4125-73

Quantity: 86,790 bottles

Product: Penicillin V Potassium for Oral Solution, USP (200 mL)by Teva

Variants: 125 mg (200,000 U) per 5 mL, 200 mL, Rx Only

Lot Numbers:

35446318B (Exp 05/2022)

35447947A (Exp 03/2023)

NDC:

00093-4125-74

Quantity: 25,416 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89255

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Pharmacies

Manufactured In: United States

Units Affected: a) 86,790 and b) 25,416 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Teva Penicillin V Potassium for Oral Solution (125 mg per 5 mL) packaged in 100 mL (NDC 00093-4125-73) and 200 mL (NDC 00093-4125-74) bottles.

Identify the lot number and expiration date on your medication bottle. For the 100 mL bottles, look for lots 35446365A (Exp 03/2022), 35447040A (Exp 08/2022), or 35447948B (Exp 03/2023). For the 200 mL bottles, look for lots 35446318B (Exp 05/2022) or 35447947A (Exp 03/2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Penicillin V Potassium for Oral Solution, USP (100 mL)by Teva

Variants: 125 mg (200,000 U) per 5 mL, 100 mL, Rx Only

Lot Numbers:

35446365A (Exp 03/2022)

35447040A (Exp 08/2022)

35447948B (Exp 03/2023)

NDC:

00093-4125-73

Quantity: 86,790 bottles

Product: Penicillin V Potassium for Oral Solution, USP (200 mL)by Teva

Variants: 125 mg (200,000 U) per 5 mL, 200 mL, Rx Only

Lot Numbers:

35446318B (Exp 05/2022)

35447947A (Exp 03/2023)

NDC:

00093-4125-74

Quantity: 25,416 bottles