Agency classClass IOur severity:Severe FDA (Drugs)·D-0570-2025·Announced 2025-07-09

Buffered penicillin G potassium vials may actually contain cefazolin for injection

Buffered Penicillin G Potassium for Injection is being recalled because some vials of cefazolin for injection were incorrectly labeled as penicillin G potassium 20 million units.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

Buffered Penicillin G Potassium for Injection, USP, 20,000,000 units, for intravenous use, sterile, prescription only, manufactured in Austria by Sandoz GmbH for Sandoz Inc. of Princeton, New Jersey, NDC 0781-6136-94, is being recalled. The source does not state a quantity.

The stated reason is a label mix-up: some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as Penicillin G Potassium for Injection, USP, 20 million Units. The FDA classified the action as Class I, its most serious classification.

Affected lots are PG4360 and PG4362, expiring 11/30/2027. Distribution was nationwide in the USA. The vials are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the NDC and lot numbers above, quarantine it, and follow the instructions issued by Sandoz.

The recalled product

Product: PENICILLIN G POTASSIUM (PENICILLIN G POTASSIUM)
Brand: PENICILLIN G POTASSIUM
Manufacturer: Sandoz Inc
Category: Drug — Injectable antibiotic
Hazard: label-mix-up
wrong-drug
cefazolin
penicillin
class-i

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 (3)

Lot # PG4360
PG4362
Exp. 11/30/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sandoz Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Sandoz Inc

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