CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report
Lidocaine Ointment USP, 5% (Generic for Xylocaine) recalled
Preferred Pharmaceuticals is recalling Lidocaine Ointment USP, 5% (Generic for Xylocaine), distributed nationwide in the US. The recall was initiated on 28 Sep 2026 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-0013-2027
- FDA event ID
- 99994
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Sep 2026
- FDA classified
- 6 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 28 Sep 2026 | Recall initiated by company | |
| 6 Oct 2026 | Classified by FDA | +8 days |
| 14 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications
Which lots are affected?
Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
Where was it sold?
USA Nationwide
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 Oct 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 Preferred Pharmaceuticals
All 56| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
Other Lidocaine recalls
All 120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaine | SUN Pharma /Taro | Potency & Assay | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |