Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations
Teligent Pharma, Inc. is recalling all unexpired batches of Lidocaine Ointment USP, 5% nationwide and in Puerto Rico because the manufacturer is discontinuing its stability study program, a violation of good manufacturing practices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing-practice deviation. The source text does not report any illnesses, injuries, or deaths. The recall is based on a procedural/regulatory violation (discontinuation of stability studies) rather than confirmed product defect or contamination, making it a precautionary recall.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Ointment USP, 5% (35.44 g/1¼ oz tubes, NDC 52565-008-14) distributed nationwide in the USA and Puerto Rico. The recall affects all products within expiry, including Batch 16389 (Exp. 2/29/2024) and Batch 16452 (Exp. 2/29/2024).
The recall has been issued because Teligent Pharma is discontinuing its stability study program. This action constitutes a deviation from current Good Manufacturing Practice (cGMP) requirements for pharmaceutical products.
Consumers who have this lidocaine ointment should stop using it and consult their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacies should quarantine affected stock and contact their suppliers for return instructions.
The recalled product
- Product
- Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.
- Manufacturer
- Teligent Pharma, Inc.
- Hazard
- cGMP-deviation
- stability-study-discontinuation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch: 16389
- Exp. 2/29/2024
- 16452
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27