Bicillin L-A 2.4 million unit vials recalled after particulates found
Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 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), 2,400,000 units per 4 mL, 4 mL vial, prescription only, distributed by Pfizer Inc. of New York and made in Austria, carton NDC 60793-702-10 and syringe NDC 60793-702-04, is being recalled. The action covers 19,279 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 GT2598 and GT2599 expiring 09/30/26, HK2909 expiring 02/28/27 and HR9969 expiring 04/30/27, 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
- Affected units
- 19,279
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 (9)
- Lots GT2598
- GT2599
- Exp 09/30/26
- HK2909
- Exp 02/28/27
- HR9969
- Exp 04/30/27
- HR9984
- Exp 08/31/27.
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 →Related recalls
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