Lidocaine Ointment USP recall
FDA recall D-0848-2026 · initiated Aug 31, 2026
SUN PHARMA /TARO recalled Lidocaine Ointment USP in Aug 2026 — an FDA Class II recall (D-0848-2026) because Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 65,328 50g jars
Details
- Product
- Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5
- Recalling company
- SUN PHARMA /TARO
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 31, 2026
- FDA report date
- Sep 23, 2026
Frequently asked
- Was Lidocaine Ointment USP recalled?
- SUN PHARMA /TARO recalled Lidocaine Ointment USP in Aug 2026 — an FDA Class II recall (D-0848-2026) because Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine Ointment USP recalled?
- Per the FDA enforcement record, the reason for recall D-0848-2026 was: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
- Is a recalled Lidocaine Ointment USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lidocaine Ointment USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # AD48154, Exp: 4/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0848-2026.