Allergy Medication recalls

The FDA has published 348 recalls involving allergy medication since 2012. The latest was reported on 16 Sep 2026. Most were for potency & assay. Perrigo has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls348since 2012

Last 12 months9reported

Class I144% of total

Ongoing27latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '24 0 3 0Feb 1 2 0May 0 1 1Aug 0 2 0Nov 0 0 0Feb 0 3 0May 1 2 0Aug 1 0

Severity split

Class I 14 4%Class II 266 76%Class III 68 20%

Why allergy medication is recalled

Companies

Perrigo319%
Ohm Laboratories216%
Central Admixture Pharmacy Services206%
L. Perrigo134%
SterRx123%
Aurolife Pharma113%
Sun Pharmaceutical Industries103%
Mckesson Medical-Surgical Inc. Corporate Office93%

Brands

By year

202672%
2025103%
202482%
20235315%
20226920%
2021195%
202072%
20194914%
2018195%
2017216%

Ongoing allergy medication recalls

27 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine	American Regent	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS I	Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
8 Jul 2026Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
17 Jun 2026Drug	CLASS III	Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine	Fresenius Kabi USA	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine	International Medication Systems	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide

All allergy medication recalls, newest first

348 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine	American Regent	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS I	Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
8 Jul 2026Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
17 Jun 2026Drug	CLASS III	Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine	Fresenius Kabi USA	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine	International Medication Systems	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled	Pfizer	Sterility	Nationwide
9 Jul 2025Drug	CLASS II	BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health	Tailstorm Health	Sterility	Nationwide
23 Apr 2025Drug	CLASS II	Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules recalled	Chattem	Nitrosamine Impurity	Nationwide
16 Apr 2025Drug	CLASS II	Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
19 Mar 2025Drug	CLASS II	Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg recalled	Chattem	Nitrosamine Impurity	Nationwide
22 Jan 2025Drug	CLASS III	Diphenhydramine HCl 25 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Diphenhydramine HCl 50 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
22 Jan 2025Drug	CLASS III	Diphenhydramine HCl 25 mg per, Akron Pharma recalled	Akron Pharma	Other	Nationwide
6 Nov 2024Drug	CLASS II	Chlorpheniramine Maleate recalled by BLI InternationalChlorpheniramine Maleate 4mg	BLI International	Potency & Assay	MO
30 Oct 2024Drug	CLASS II	NORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalled	Fresenius Kabi Compounding	Manufacturing (CGMP) Deviations	Nationwide
30 Oct 2024Drug	CLASS II	EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per Single Dose recalled	Fresenius Kabi Compounding	Manufacturing (CGMP) Deviations	Nationwide
30 Oct 2024Drug	CLASS II	NORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalled	Fresenius Kabi Compounding	Manufacturing (CGMP) Deviations	Nationwide
28 Feb 2024Drug	CLASS II	Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin	Henry Schein Inc. and Glove Club HSI Gloves	Packaging Defects	Nationwide
28 Feb 2024Drug	CLASS II	Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate	Baxter Healthcare	Packaging Defects	Nationwide
31 Jan 2024Drug	CLASS II	Fexofenadine Hydrochloride Tablets, USP 180mg recalledFexofenadine Hydrochloride	SUN Pharmaceutical Industries	Sterility	Nationwide
17 Jan 2024Drug	CLASS II	Desloratadine Tablets USP 5mg a) recalled by Lupin PharmaceuticalsDesloratadine	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
6 Sep 2023Drug	CLASS II	EPINEPHrine added to 0.9% sodium chloride, 4mg/ (16 mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	EPINEPHrine added to dextrose 5%, 4mg/, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	EPINEPHrine 8mg/ added to dextrose 5%, 32 mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide

Should you stop taking Allergy Medication?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.

Alert me about Allergy Medication

One email the day a new recall is posted for Allergy Medication. Unsubscribe any time.

At a glance

Latest recall: 16 Sep 2026
First on record: 25 Jul 2012
Class I share: 4%
Ongoing: 27

Drug classes

Injectable & IV Drugs 4,623Pain Medication 1,518Creams, Ointments & Gels 928Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 494Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.