Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class I · High risk Ongoing Jun 24, 2026

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…

JB Chemicals and Pharmaceuticals Ltd NDC 16571-401-10 D-0732-2026

Class III · Low risk Ongoing Jun 1, 2026

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc…

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries INC NDC 66336-561-30 D-0654-2026

Class I · High risk Ongoing Jun 1, 2026

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle…

Reason Microbial Contamination of Non-Sterile Products

Beekeeper's Naturals USA INC. D-0620-2026

Class II · Moderate risk Ongoing Apr 8, 2026

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L…

Reason Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

Apotex Corp. NDC 60505-0815-0 D-0510-2026

Class I · High risk Ongoing Dec 12, 2025

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE…

Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as…

Medinatura New Mexico, inc. NDC 62795-4006-9 D-0289-2026

Class I · High risk Ongoing Dec 12, 2025

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC…

Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as…

Medinatura New Mexico, inc. NDC 62795-4005-9 D-0288-2026

Class II · Moderate risk Ongoing Nov 12, 2025

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…

Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Medical Products Laboratories, Inc. NDC 0363-3114-01 D-0179-2026

Class III · Low risk Ongoing Sep 12, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Tablet/Capsules Imprinted with Wrong ID

JB Chemicals and Pharmaceuticals Ltd NDC 16571-402-50 D-0033-2026

Class III · Low risk Ongoing Sep 12, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Tablet/Capsules Imprinted with Wrong ID

JB Chemicals and Pharmaceuticals Ltd NDC 16571-402-10 D-0032-2026

Class II · Moderate risk Ongoing Mar 26, 2025

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219…

Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…

Chattem Inc D-0362-2025

Class II · Moderate risk Ongoing Mar 13, 2025

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 72657-129-35 D-0348-2025

Class II · Moderate risk Ongoing Mar 4, 2025

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor…

Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug…

Chattem Inc D-0266-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building…

Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc. NDC 71399-8026-02 D-0199-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building…

Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc. NDC 71399-8028-2 D-0198-2025

Class III · Low risk Ongoing Dec 12, 2024

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building…

Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Akron Pharma, Inc. NDC 71399-8028-1 D-0197-2025

Class II · Moderate risk Ongoing Sep 24, 2024

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29…

Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.

Glenmark Pharmaceuticals Inc., USA NDC 59467-700-27 D-0006-2025

Class II · Moderate risk Ongoing Feb 14, 2024

Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek…

Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Golden State Medical Supply Inc. NDC 60429-195-15 D-0349-2024

Class II · Moderate risk Ongoing Feb 9, 2024

Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc…

Reason CGMP Deviations: potential presence of Burkholderia cepacia complex

Apotex Corp. NDC 60505-0829-1 D-0326-2024

Class II · Moderate risk Completed Jan 18, 2024

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30…

Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Sun Pharmaceutical Industries INC NDC 51660-998-30 D-0273-2024

Class II · Moderate risk Ongoing Dec 28, 2023

Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice…

Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…

Seaway Pharma Inc. NDC 63868-607-01 D-0214-2024

Class I · High risk Ongoing Dec 26, 2023