MedDRA preferred term · the product was stored wrongly

Product storage error: adverse event reports recording this term

85,392 reports to FDA record it, 2010–2026; 0.4% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

85,392
reports recording the term: 0.4% of all reports; 10,209
reports, 12 months to June 2026: 12,596 in the 12 months before; 9.3%
marked serious by the reporter: 57.4% across all reports; 0.3%
record death among outcomes, as reported: 9.1% across all reports

85,392 reports in FDA's adverse event database record the MedDRA term "Product storage error" (in plain words, the product was stored wrongly): 0.4% of all reports received between October 2010 and June 2026. Coders pick the term that best matches the reporter's description.

10,209 reports recorded it in the 12 months to June 2026, down 19% from 12,596 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 9.3% are marked serious, 0.3% include death among the outcomes and 3.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Repatha, Lantus Solostar and Enbrel. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Repatha	PCSK9 inhibitor	6,651	4.3%
Lantus Solostar	Insulin analog	5,157	11.3%
Enbrel	Tumor necrosis factor blocker	4,166	0.7%
Prolia	RANK ligand inhibitor	3,249	2.4%
Aimovig	—	2,970	5.7%
Dupixent	Interleukin-4 receptor alpha antagonist	2,875	0.6%
Orencia	Selective T cell costimulation modulator	2,122	2%
Albuterol sulfate	beta2-Adrenergic agonist	1,801	4%
Aranesp	Erythropoiesis-stimulating agent	1,622	4.4%
Stelara	Interleukin-12 antagonist	1,363	1.6%
Cosentyx	Interleukin-17A antagonist	1,350	0.9%
Humira	—	1,330	0.2%
Tremfya	Interleukin-23 antagonist	1,201	3.7%
Toujeo	Insulin analog	1,191	7.7%
Lantus	Insulin analog	1,147	2.9%
Epogen	Erythropoiesis-stimulating agent	1,121	26%
Humalog	Insulin analog	971	1.4%
Risankizumab	—	906	22.8%
Skyrizi	Interleukin-23 antagonist	896	1.1%
Neulasta	Leukocyte growth factor	858	1.1%
Eliquis	Factor Xa inhibitor	762	0.6%
Sterile diluent	Insulin analog	728	22.6%
CombiPatch (estradiol/norethindrone acetate transdermal system)	Estrogen	722	20%
Benlysta	B lymphocyte stimulator-specific inhibitor	719	2.8%
Insulin glargine	Insulin analog	719	2.6%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.4% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Insulin analog	11,587	4%	2.3%
PCSK9 inhibitor	6,997	3.9%	1.4%
Tumor necrosis factor blocker	5,876	0.6%	0.5%
RANK ligand inhibitor	3,721	2.2%	2.1%
Interleukin-4 receptor alpha antagonist	3,074	0.6%	1.1%
Erythropoiesis-stimulating agent	2,944	4.4%	0.2%
beta2-Adrenergic agonist	2,442	2.7%	0.3%
GLP-1 receptor agonist	2,306	0.6%	0.2%
Selective T cell costimulation modulator	2,292	1.8%	1.4%
Interleukin-23 antagonist	2,187	1.9%	1.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.2%189

2 to 111.3%1,102

12 to 171%891

18 to 446.6%5,671

45 to 6411.8%10,105

65 to 747.8%6,643

75 and over6%5,144

Age not given65.2%55,647

Patient sex

Female39.3%33,569

Male23.5%20,058

Not given37.2%31,765

Grey bar: all 20,646,523 reports in the database. 95.8% of these reports give the United States as the country.

Questions about "Product storage error"

What does "Product storage error" mean in an adverse event report?

In plain language: the product was stored wrongly. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record product storage error?

85,392 reports through June 2026 (0.4% of all reports), 10,209 of them in the latest 12 months.

Which drugs appear most often in these reports?

Repatha (6,651), Lantus Solostar (5,157), Enbrel (4,166), Prolia (3,249) and Aimovig (2,970). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.