CLASS III Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
equate, Allergy Relief D, Fexofenadine HCl recalled
Dr. Reddy's Laboratories is recalling equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl, distributed nationwide in the US. The recall was initiated on 4 Jan 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0383-2022
- FDA event ID
- 89364
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Jan 2022
- FDA classified
- 18 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 4 Jan 2022 | Recall initiated by company | |
| 18 Jan 2022 | Classified by FDA | +14 days |
| 26 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.
Where it was distributed
Nationwide in the USA
Stores named: Walmart
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #s: a) (20-count): 79C002624A, Exp. 4/30/2022; AC2000968B, Exp. 8/31/2022; AC2103328F; AC2103330E, Exp.1/31/2023; AC2106452I, Exp. 3/31/2023. b) (30-count): 79C002625A, Exp. 4/30/2022; AC2103328E; AC2103330F, Exp. 1/31/2023; AC2106452G, Exp. 3/31/2023.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 89364This product is part of a recall event; the main page for the event is QC Quality Choice, Fexofenadine HCl 60mg recalled.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |