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.
3 recalls
-
Class II Ongoing
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 6019…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
- Lots / codes
- Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 760 bottles
- Recall started
- July 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0937-2023
-
Class II Ongoing
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
- Lots / codes
- Lot #: a) OXL202, exp 6/30/2025; OXL204, exp 6/30/2025; OXL301, exp 12/31/2025; OXL205, exp 11/30/2025; b) OXL201, exp 5/31/2025; OXL203, exp 6/30/2025
- Distribution
- Nationwide in the USA
- Quantity
- 65,710 vials for 1 g and 2 g strength
- Recall started
- July 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0936-2023
-
Class II Ongoing
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
- Lots / codes
- Lot: OXG301, Exp 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 65,710 vials for 1 g and 2 g strength
- Recall started
- July 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0935-2023
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.