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Class III: unlikely to cause harmTerminated

Dr. Reddy's Laboratories Allergy Relief D Fexofenadine HCl Recall

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Releas…

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Risk level
Class III
Reported by FDA
Dec 15, 2021
Recall ID
D-0274-2022
Check your lot numberHow we source this data

Summary

Dr. Reddy's Laboratories recalled Allergy Relief D Fexofenadine HCl starting Nov 12, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0274-2022 on Dec 15, 2021. Reason: Failed dissolution specifications. Status: Terminated.

Why it was recalled

Failed dissolution specifications

Product description

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.

Lot numbers, UPCs & expiration codes

Lot #: AC2103329B

Where it was sold

USA Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0274-2022
Classification
Class III
Status
Terminated
Recall initiated
Nov 12, 2021
FDA report date
Dec 15, 2021
Quantity
9,984 cartons
Recall type
N/A
Recalling firm
Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0274-2022, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
89042
Address
107 College Rd E
Code information
Lot #: AC2103329B
Postal code
08540-6623
Report date
Dec 15, 2021
Product type
Drugs
Recall number
D-0274-2022
Classification
Class III
Recalling firm
Dr. Reddy's Laboratories, Inc.
Product quantity
9,984 cartons
Termination date
Jun 23, 2023
Reason for recall
Failed dissolution specifications
Product description
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
Distribution pattern
USA Nationwide.
Recall initiation date
Nov 12, 2021
Initial firm notification
Letter
Center classification date
Dec 7, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0274-2022, published Dec 15, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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