Drug Recall: Mucus Relief D Subpotent Tablets
Dr. Reddy's Laboratories is recalling Mucus Relief D (Guaifenesin Pseudoephedrine HCl ER Tablets) nationwide due to subpotency. The affected product was distributed to Walgreen Co. stores across the USA.
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: This is an FDA Class III recall for a subpotent drug with no reported illnesses or injuries. The source text does not indicate any patient harm or safety hazard—only that the drug contains less active ingredient than labeled. Per the rubric, Class III recalls are typically scored 1 or 2, and with no reported adverse events, a score of 1 applies.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60 mg, due to subpotency (lower-than-specified potency).
The affected product is packaged in 36-count blister packs placed in cartons and was distributed by Walgreen Co. across the USA. The recall involves 18,336 cartons with lot numbers AT2102065A and AT2102065B, expiration date 04/2023. The drug was manufactured in India.
This is a voluntary recall initiated by the manufacturer. Consumers who have purchased this product should stop using it and return it to the point of purchase or contact Dr. Reddy's Laboratories, Inc. for additional information.
The recalled product
- Product
- Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- Affected units
- 18,336
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 (3)
- Lot #: AT2102065A
- AT2102065B
- Exp 04/2023.
Distribution
Distributed nationwide across the United States.
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