Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
5 recalls
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Class II Ongoing
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…
Reason: CGMP Deviations; particulates identified during visual inspection
Lots, distribution and 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
- Lots / codes
- Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
- Distribution
- Nationwide in the USA
- Quantity
- 19,279 vials
- Recall started
- July 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0545-2025
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Class I Ongoing
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Reason: Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Lots, distribution and details
- Lots / codes
- Lot # PG4360, PG4362, Exp. 11/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- unknown
- Recall started
- June 27, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0570-2025
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Class I Ongoing
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton)…
Reason: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Lots, distribution and details
- Product
- Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
- Lots / codes
- Lot # PG4360, PG4362, Exp. 11/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 208,300 vials
- Recall started
- June 27, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0569-2025
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Class II Terminated
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Lots, distribution and details
- Lots / codes
- 567951
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Quantity
- 70 vials
- Recall started
- February 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0373-2024
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Class II Ongoing
Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx 29183 Exp, 5/21/2014
- Distribution
- Florida
- Quantity
- 7 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1455-2014
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.