Diclofenac Sodium Topical Solution recalled for defective container
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% w/w due to a defective container. The recall affects approximately 2,664 bottles 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: The recall is classified as FDA Class II and involves a defective container rather than a contamination or stability issue with direct reports of harm. No illnesses, injuries, or hospitalizations are reported in the source text, and the hazard is defect-related rather than a high-risk pathogen or allergen issue.
Plain-English summary
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl oz (150 mL) plastic bottles (NDC 52565-002-05) due to a defective container. Lot #15188 with an expiration date of February 2023 is affected by this recall.
The defective container poses a risk to product integrity and safety. Approximately 2,664 bottles were distributed nationwide in the United States.
Healthcare providers and patients who have this medication should stop using it and contact their pharmacy or healthcare provider for guidance on obtaining a replacement or alternative medication. Patients should not discontinue their diclofenac therapy without medical advice.
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 52565-002-05
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical anti-inflammatory
- Hazard
- defective-container
- product-integrity
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 #: 15188
- Exp 2/2023
Distribution
Distributed nationwide across the United States.
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