The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0544-2025·Announced 2025-08-06

Bicillin L-A penicillin vials recalled after particulates found during visual inspection

Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

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: Risk-of-harm product: visible particulates in an injectable suspension, with no injury reported in the source.

Plain-English summary

Bicillin L-A (penicillin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL vial, prescription only, distributed by Pfizer Inc. of New York and made in Austria, carton NDC 60793-701-10 and syringe NDC 60793-701-02, is being recalled. The action covers 50,855 2 mL vials.

The stated reason is CGMP deviations: particulates were identified during visual inspection. The FDA classified the action as Class II. The source does not report any injury having occurred.

Affected lots include HJ3235 expiring 09/30/26, GL2954 and HP6222 expiring 01/31/27 and HR9967 expiring 05/31/27, together with the further lots listed in the recall notice. Distribution was nationwide in the USA.

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

The recalled product

Product
BICILLIN L-A (PENICILLIN G BENZATHINE)
Brand
BICILLIN L-A
Manufacturer
Pfizer Inc.
Category
Drug — Injectable antibiotic
Hazard

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 (13)

  • Lots: HJ3235
  • Exp 09/30/26
  • GL2954
  • HP6222
  • Exp
  • 01/31/27
  • HR9967
  • Exp 05/31/27
  • HP6232
  • LT5190
  • Exp 09/30/27
  • HP6228
  • Exp 10/31/27

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Pfizer 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 →

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