The children's fever reducer shortage of 2022

On Jan. 20, 2023, FDA issued a guidance that took effect the day it was published. It allowed outsourcing facilities, the federally registered compounders known as 503B facilities, to make ibuprofen oral suspension for hospitals and health systems. The agency's announcement¹ said it was acting "amid record high demand" during a surge in three viruses at once: COVID-19, respiratory syncytial virus (RSV) and influenza.

At the center of it was the children's liquid fever reducer sold on drugstore shelves. Through late 2022 and into 2023, families reported trouble finding children's liquid acetaminophen and ibuprofen, and hospitals told FDA they were having difficulty buying the same suspensions for pediatric patients and for adults who cannot swallow tablets, according to the guidance².

This episode is worth reconstructing because it ran almost entirely outside the federal shortage system. The early-warning law that feeds FDA's shortage work covers prescription drugs, so the agency had no formal advance notice. This piece rebuilds the timeline from FDA, CDC and congressional documents, then uses FDA's current drug listing data to show how the supply of these two medicines is organized. For the wider picture, see our piece on pediatric drug shortages.

Three viruses peaking in the same weeks

RSV usually builds in the fall and fades by spring. In 2022 it came early and ran high. A CDC analysis in Morbidity and Mortality Weekly Report⁵ found that the national RSV epidemic began in June 2022, peaked in November and lasted 32 weeks. At the peak, 19% of PCR tests for RSV were positive, above the 13% to 16% seen in prepandemic seasons.

Influenza arrived on top of it. A separate CDC report on children and adolescents⁶ rated 2022–23 a high-severity flu season for people under 18, with flu-related outpatient visits and hospitalizations peaking in late November and early December. COVID-19 was still circulating. FDA's guidance made the connection directly, noting that each of the three viruses "may produce fever in young children."

That winter also brought a shortage of the liquid form of a common children's antibiotic, covered in our account of the amoxicillin shortage of 2022 and 2023. FDA's report to Congress for 2022¹⁴ names amoxicillin oral suspension as a shortage caused by "the recent confluence of respiratory illnesses, including COVID-19, RSV, and seasonal influenza." The fever reducers never got that treatment, and the reason is written into the statute.

Why the shelves emptied without an FDA shortage notice

Federal shortage reporting rests on section 506C⁷ of the Food, Drug, and Cosmetic Act, which requires manufacturers to tell FDA about discontinuances and manufacturing interruptions that are likely to disrupt US supply. The section defines the drugs it covers as those subject to section 503(b)(1), the prescription-drug provision. Makers of nonprescription fever reducers had no obligation to send that warning. FDA says⁹ manufacturers provide most of the shortage information it receives, so the gap mattered. Even for prescription drugs, the same 2022 report conceded that FDA "generally does not receive notice or adequate information from drug manufacturers regarding sudden increases in demand."

FDA also judges shortages nationally. Its shortage FAQ⁸ says a drug is in shortage when, "on a nationwide level, supply is not meeting current demand." The agency's description of the 2022 problem pointed to demand. Its question-and-answer page⁴ on compounded fever reducers said ibuprofen and acetaminophen oral suspensions "have experienced increased demand since the fall of 2022," and that "companies continue to report inventory and are manufacturing at maximum output."

One later provision does reach these products. The 2020 CARES Act made registered firms report each year how much of every listed drug they make, and FDA says the requirement covers⁹ OTC monograph drugs as well as approved ones. Those reports look back over a full calendar year, so they help with pattern-spotting more than with a sudden winter surge. Our explainer on the CARES Act and shortage reporting covers how they work.

What FDA did, in order

FDA's policy covered ibuprofen only, in the 100 mg per 5 mL strength. Acetaminophen was left out. The April revision says FDA was not addressing acetaminophen suspensions "to allow time for the review of additional considerations." The agency did not spell those out in the document.

In their letter, the House members described "an unprecedented demand for over-the-counter pediatric fever-reducing medications" and said that "demand for these medicines is outpacing supply." Among its requests were a public outreach campaign for caregivers and more manufacturer transparency about where supply was located.

Many labels, fewer sources

To see how the market for these liquids is built, GxRadar pulled every single-ingredient, nonprescription acetaminophen and ibuprofen suspension in FDA's National Drug Code directory, as published through the openFDA NDC endpoint¹⁰ in November 2026. The directory reflects listings as of today; shelves in 2022 may have looked different, and a listing says nothing about volume. It still shows the structure.

Source: GxRadar analysis of FDA NDC directory records via openFDA, November 2026. Counts include only products whose sole active ingredient is acetaminophen or ibuprofen and whose dosage form is listed as a suspension.

Each drug reaches the shelf by different legal routes. Acetaminophen liquids are marketed under an OTC monograph, a standing set of conditions any compliant product can follow without its own FDA approval; our piece on the 2020 OTC monograph reform explains that system. Ibuprofen is different. FDA's internal analgesic rulemaking history¹⁵ shows the agency proposed adding ibuprofen to the monograph in 2002, but in the current directory nearly every OTC ibuprofen suspension is sold under an approved ANDA or NDA.

Ibuprofen's numbers stand out. Seventy-one labelers list these products, but 155 of the 218 approved listings trace back to just three ANDAs. Many of those labels are store brands or products of repackagers and relabelers. A shopper scanning a shelf of different boxes may be looking at a handful of approved formulations, which helps explain why a demand spike can empty several brands at once.

Compounding, and its limits

FDA framed the compounding policy as a stopgap. The guidance states that compounded drugs "have not undergone FDA premarket review for safety, effectiveness, and quality," and that the agency recommends FDA-approved drugs "whenever possible." It set out quality steps for outsourcing facilities and noted the timing: in 2022 and 2023, FDA had received reports of children's medicines abroad contaminated with diethylene glycol and ethylene glycol.

Those were not abstract concerns. On Jan. 23, 2023, the World Health Organization¹² said contaminated cough syrups for children had been reported in at least seven countries and were associated with more than 300 deaths in three of them, mostly among children under 5. Our history of diethylene glycol contamination in medicines traces how often that solvent has turned up in liquid drugs. FDA's Q&A⁴ added that compounded acetaminophen and ibuprofen suspensions would still need child-resistant packaging under the 1970 law described in our piece on child-resistant caps.

Questions about which product, strength or measuring device fits a particular child belong with a pharmacist or the child's clinician. Labels and dosing cups differ between infant and children's products, a point covered in our article on dosing devices and liquid medicine labels. If a store is out, our guide to what to ask when the pharmacy has a back order lists questions to bring to the counter.

Where the policy stands

The guidance said FDA would publish a Federal Register notice giving at least 60 days' warning before withdrawing it. As of November 2026, the April 2023 revision was still posted on FDA's guidance page², whose last content update is dated April 12, 2023. The structural gap it worked around is unchanged in the text of section 506C⁷, which still limits the shortage-notice duty to prescription drugs.