CLASS II ONGOING Drug recall · Reported 6 Aug 2025 · FDA Enforcement Report
Bicillin L-A (penicillin G benzathine injectable recalled by Pfizer
Pfizer is recalling Bicillin L-A (penicillin G benzathine injectable suspension) per-vial, distributed nationwide in the US. The recall was initiated on 10 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0545-2025
- FDA event ID
- 97220
- Recalling firm
- Pfizer, New York, NY
- Brand
- Bicillin L-a
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2025
- FDA classified
- 30 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 10 Jul 2025 | Recall initiated by company | |
| 30 Jul 2025 | Classified by FDA | +20 days |
| 6 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; particulates identified during visual inspection
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Bicillin L-A (penicillin G benzathine injectable suspension) per-vial recalled?
Yes. Pfizer recalled Bicillin L-A (penicillin G benzathine injectable suspension) per-vial on 10 Jul 2025. The recall is Class II and its status is Ongoing. Recall number D-0545-2025.
Why was it recalled?
CGMP Deviations; particulates identified during visual inspection
Which lots are affected?
Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer
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|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
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| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg/ 5 mg/mL) per Single-dose recalledDobutamine | Pfizer | Other | Nationwide |
Other Penicillin G Benzathine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |