Diclofenac Sodium Topical Gel Recalled for Failed pH Specifications
Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel nationwide due to failed pH specifications. Affected batch XHBG expires August 31, 2027.
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 a Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect involving failed pH specifications. Per the severity rubric, FDA Class III recalls are typically scored 1–2. Since there are no reported cases of harm and the hazard is a specification failure rather than a substantiated safety threat, a Moderate (2) score is appropriate.
Plain-English summary
Cipla USA, Inc. is recalling Diclofenac Sodium Topical Gel, 1%, in 100-gram tubes (NDC 76282-103-39) due to failed pH specifications. The recall affects 92,376 units distributed nationwide in the United States.
The affected product is identified by batch number XHBG with an expiration date of August 31, 2027. The gel was manufactured by DPT Laboratories, Ltd., located at 307 E. Josephine Street, San Antonio, Texas 78215.
This is a Class III recall initiated by the manufacturer.
The recalled product
- Product
- DICLOFENAC SODIUM (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Topical Gel
- Hazard
- specification-failure
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)
- Batch XHBG
- Exp. 08/31/2027
Distribution
Distributed nationwide across the United States.
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