Diclofenac Sodium Topical Solution recalled for defective container
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% due to a defective container. The recall affects 5,400 units distributed nationwide.
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 initiated voluntarily by the manufacturer. The source text identifies only a defective container as the hazard with no reports of illness or injury. Under the severity rubric, this falls under "Minor labeling errors, low-risk contamination, voluntary precautionary recalls," which corresponds to a Moderate classification.
Plain-English summary
Teligent Pharma, Inc. is voluntarily recalling Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl oz (150 mL) plastic bottles (NDC 70512-025-05) due to defective container issues. The recall affects 5,400 units distributed nationwide within the United States.
The affected product includes two lot numbers with the following expiration dates: Lot #15028, Exp 1/2023; and Lot #15379, Exp 3/2023. The defective container poses a potential risk to patients using this prescription medication.
Consumers with this product should contact their healthcare provider or pharmacist before using any remaining supply. Patients should not discontinue use of their medication without consulting their healthcare provider for guidance on alternative treatments.
The recalled product
- Product
- Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Hazard
- Affected units
- 5,400
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 (4)
- Lot #: 15028
- Exp 1/2023
- 15379
- Exp 3/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →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 · defective container
See all →- High
- ModeratePureLife benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateBurkhart benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePearson Quality benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateDental City benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24