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.
4 recalls
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Class II Ongoing
Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05
Reason: Failed Content Uniformity Specifications
Lots, distribution and details
- Lots / codes
- Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- September 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2027
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Class II Ongoing
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
- Lots / codes
- Lot #: 6133986, Exp. Date 02/2029
- Distribution
- Nationwide within in the USA
- Quantity
- 37,250 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0729-2026
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Class II Ongoing
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Reason: Presence of Particulate Matter: Hair was found in products
Lots, distribution and details
- Product
- Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
- Lots / codes
- Lot #: 6130235, Exp. Date 02/2027
- Distribution
- Nationwide within in the USA
- Quantity
- 93,250 vials
- Recall started
- July 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0728-2026
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Class II Ongoing
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, Yor…
Reason: Defective container: cracked/broken cartridges
Lots, distribution and details
- Product
- 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
- Lots / codes
- Lot: D05337B, expires: 06-30-2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Recall started
- October 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0228-2026
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.