Doan's Pain Relieving Cream Recalled for Packaging Labeling Mismatch
Dr. Reddy's is recalling Doan's Pain Relieving Cream because the lot number on the outer packaging does not match the bottle. This is a Class III labeling recall.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging labeling mismatch.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol. The recall involves 23,402 cases of the 2.75 oz. tube, distributed nationwide. The specific lots affected are #2462100R (Exp 11/2018) and #2583800R (Exp 09/2018).
The recall was initiated due to a labeling error where the lot number printed on the secondary packaging does not match the lot number printed on the bottle. This discrepancy creates a risk of incorrect lot identification or expiration date tracking.
The U.S. Food and Drug Administration has classified this as a Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers should check their products for the affected lot numbers and expiration dates.
The recalled product
- Product
- Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 23,402
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)
- lots #2462100R
- Exp 11/2018
- 2583800R
- Exp 09/2018
Distribution
Distributed nationwide across the United States.
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