Why it was recalled
CGMP Deviations; particulates identified during visual inspection
Product description
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
Lot numbers, UPCs & expiration codes
Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0545-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 10, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 19,279 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0545-2025, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97220
- Address
- 235 East 42nd Street
- Code information
- Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
- Postal code
- 10017-5703
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0545-2025
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 19,279 vials
- Reason for recall
- CGMP Deviations; particulates identified during visual inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2025