Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. A superpotent drug carries inherent risk of patient harm through overdosage or excessive effects, even without reported illnesses in the source text.
Plain-English summary
Teligent Pharma, Inc., located in Buena, New Jersey, is voluntarily recalling Lidocaine Hydrochloride Topical Solution, USP, 4%, in 50 mL glass bottles (NDC 52565-009-50). The recall was initiated due to the product being superpotent.
Approximately 32,544 glass bottles were distributed nationwide within the United States and Canada. The affected lot is Lot #14218 with an expiration date of 08/2022.
Consumers and healthcare providers who have this product should stop using it and consult with a healthcare provider regarding alternative treatment options. The FDA classified this as a Class I recall on September 15, 2021. For additional information, patients should contact their healthcare provider or pharmacist.
The recalled product
- Product
- Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Anesthetic
- Affected units
- 32,544
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 (2)
- Lot #:14218
- Exp. Date 08/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teligent Pharma, Inc.
See all →- ModerateDesonide Ointment Recalled Due to cGMP Deviations
FDA (Drugs) · 2022-03-30
- ModerateTriamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation
FDA (Drugs) · 2022-03-30
- ModerateTriamcinolone Acetonide Ointment Recalled Due to cGMP Deviations
FDA (Drugs) · 2022-03-30
- HighDiflorasone Diacetate Ointment recalled due to discontinued stability studies
FDA (Drugs) · 2022-03-30
- ModerateClobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations
FDA (Drugs) · 2022-03-30
Same hazard · superpotency
See all →- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
- ModerateTriamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance
FDA (Drugs) · 2024-11-27