Diclofenac topical gel recalled after failing pH specifications
Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a failed pH specification with no stated clinical consequence.
Plain-English summary
Diclofenac Sodium Topical Gel, 1%, net weight 100 g (3.53 oz), NDC 76282-103-39, manufactured by DPT Laboratories, Ltd. of San Antonio, Texas, is being recalled by Cipla USA, Inc.
The reason given in the enforcement record is failed pH specifications.
The record lists 92,376 tubes from batch XHBG, expiry 08/31/2027. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific tube is affected and arrange a replacement.
The recalled product
- Product
- DICLOFENAC SODIUM (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Topical NSAID
- Affected units
- 92,376
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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