Bicillin L-A (penicillin G benzathine injectable suspension) recall
FDA recall D-0545-2025 · initiated Jul 10, 2025
Pfizer Inc. recalled Bicillin L-A (penicillin G benzathine injectable suspension) in Jul 2025 — an FDA Class II recall (D-0545-2025) because CGMP Deviations; particulates identified during visual inspection.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; particulates identified during visual inspection
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 19,279 vials
Details
- Product
- Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
- Recalling company
- Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 10, 2025
- FDA report date
- Aug 6, 2025
Frequently asked
- Was Bicillin L-A (penicillin G benzathine injectable suspension) recalled?
- Pfizer Inc. recalled Bicillin L-A (penicillin G benzathine injectable suspension) in Jul 2025 — an FDA Class II recall (D-0545-2025) because CGMP Deviations; particulates identified during visual inspection. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bicillin L-A (penicillin G benzathine injectable suspension) recalled?
- Per the FDA enforcement record, the reason for recall D-0545-2025 was: CGMP Deviations; particulates identified during visual inspection
- Is a recalled Bicillin L-A (penicillin G benzathine injectable suspension) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Bicillin L-A (penicillin G benzathine injectable suspension) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0545-2025.