Lower risk Drug recall · FDA · Published December 16, 2021

Teva Penicillin V Potassium Oral Solution Recall: Subpotent Risk

Teva Pharmaceuticals USA recalls Penicillin V Potassium oral solution (125 mg/5mL) due to subpotent potency. This may result in less effective treatment for infections. Affected lots and expiration dates listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0294-2022Drug Teva Pharmaceuticals USA ›

Lower-risk recall

Subpotent

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA is recalling Penicillin V Potassium oral solution because it may be less potent than labeled. This could lead to ineffective treatment for infections if used without proper dosing. Read more at govinfonow.com/recall/35422-teva-penicillin-v-potassium-oral-solution-recall-subpotent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35422-teva-penicillin-v-potassium-oral-solution-recall-subpotent-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0294-2022

Cite this page

“Teva Penicillin V Potassium Oral Solution Recall: Subpotent Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35422-teva-penicillin-v-potassium-oral-solution-recall-subpotent-risk. Based on FDA recall #D-0294-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0294-2022%22&limit=1).

The FDA announced on 2021-12-16 that Teva Pharmaceuticals USA is recalling Penicillin V Potassium for Oral Solution due to subpotency. Owners should contact the company for a refund.

How to tell if you have it

Brand: Teva Pharmaceuticals USA
Product: Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL
Sizes: 100 mL (NDC 00093-4125-73) and 200 mL (NDC 00093-4125-74)
Lots (100 mL): 35446365A, Exp 03/2022; 35447040A, Exp 08/2022; 35447948B, Exp 03/2023
Lots (200 mL): 35446318B, Exp 05/2022; 35447947A, Exp 03/2023

The hazard

The recalled Penicillin V Potassium for Oral Solution is subpotent, meaning it may not contain the labeled amount of active ingredient. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since 2013-10-11. Other recent recalls include Teva Doxylamine Succinate Tablets Recall (2022-01-18), Teva Tretinoin Capsules 10mg Recall (2022-01-10), and Teva Mimvey Tablets Recall (2022-01-07). Similar recent recalls of other products include Teva Octreotide Acetate 20mg Vial Recall (2026-03-17) and Teva Octreotide Acetate 10mg Vial Recall (2026-03-17).

How to tell if you have this one

Check the product label for the NDC code 00093-4125-73 (100 mL) or 00093-4125-74 (200 mL). Also look for the specific lot numbers and expiration dates mentioned in the recall notice.

Brand
Teva Pharmaceuticals USA
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC code 00093-4125-73 or 00093-4125-74 on the bottle label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Dec 16, 2021Firm started the recall
Dec 23, 2021FDA classified it Class II
Dec 29, 2021Published in FDA’s Enforcement Report
Nov 4, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this medication?

The recall indicates a subpotent issue, which means the medication may not work as intended. There is no mention of serious injury risk in the recall notice.

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Link to this recall

<a href="https://govinfonow.com/recall/35422-teva-penicillin-v-potassium-oral-solution-recall-subpotent-risk">Teva Penicillin V Potassium Oral Solution Recall: Subpotent Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0294-2022 (December 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0294-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.