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.
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
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.
Potency or specification failurereason.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 #s: a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/2023. b) (30-count box): 79C002624C, Exp. 4/30/2022; AC2103328B; AC2103328C; AC2103330A; AC2103330B, Exp. 1/31/2023.
Distribution pattern
Nationwide in the USA
drug · product 2 of 9
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Potency or specification failurereason.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 #: AC2106452F, Exp. 3/31/2023
Distribution pattern
Nationwide in the USA
drug · product 3 of 9
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
Potency or specification failurereason.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 #: AC2103330D, Exp.1/31/2023; AC2106452E, Exp. 3/31/2023.
Distribution pattern
Nationwide in the USA
drug · product 4 of 9
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.
Potency or specification failurereason.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 #s: a) (10-count): AC2103328D, Exp. 1/31/2023. b) (20-count) :AC2000968C, Exp. 8/31/2022. c) (30-count): AC2103330C, Exp. 1/31/2023; AC2106452D, Exp. 3/31/2023.
Distribution pattern
Nationwide in the USA
drug · product 6 of 9
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.
Potency or specification failurereason.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 #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.
Distribution pattern
Nationwide in the USA
drug · product 7 of 9
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Potency or specification failurereason.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 #s: 79C002624D; 79C002625C, Exp. 4/30/2022.
Distribution pattern
Nationwide in the USA
drug · product 8 of 9
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
