Sun Pharma /Taro recall: Lidocaine Ointment USP
Sun Pharma /Taro is recalling Lidocaine Ointment USP – 65,328 50g jars. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on August 31, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Lidocaine Ointment USP |
| Brand | Sun Pharma /Taro |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 31, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 65,328 50g jars |
| Recall ID | 99794 |
Recalled products
- 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
- FDA recall number
- D-0848-2026
- Codes, lots and dates
- Lot # AD48154, Exp: 4/30/2027.
- Quantity
- 65,328 50g jars
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99794
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Hawthorne, NY, United States
Why it was recalled
The reason the FDA lists: “Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the USA”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99794, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Sun Pharma /Taro Lidocaine Ointment USP recalled?
Yes. Sun Pharma /Taro recalled it on August 31, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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).
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.