Recall events
/
Event 89042
Event summary
Timeline bucket November 12, 2021
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Dr. Reddy's Laboratories, Inc.
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
9 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 9
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
D-0267-2022
Recall number D-0267-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 4896 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329E, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12339]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 9
Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
D-0268-2022
Recall number D-0268-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 14976 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329I, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16781]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 9
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
D-0269-2022
Recall number D-0269-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 5016 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329F, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13073]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 9
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.
D-0270-2022
Recall number D-0270-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 2352 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329H, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16414]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 9
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
D-0271-2022
Recall number D-0271-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 2184 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329D, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12686]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 9
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
D-0272-2022
Recall number D-0272-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 2496 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329G, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16249]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 9
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
D-0273-2022
Recall number D-0273-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329C, Exp 1/2023
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16785]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 9
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.
D-0274-2022
Recall number D-0274-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 9,984 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329B
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16254]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 9
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
D-0275-2022
Recall number D-0275-2022
Initiated November 12, 2021
Classification Class III
Status Terminated
Quantity 2,928 cartons
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed dissolution specifications
Code information Lot #: AC2103329A
Distribution pattern USA Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[12559]
FDA event record
· Exact recall-number query on openFDA
