The amoxicillin shortage of 2022 and 2023

On Oct. 28, 2022, FDA declared a national shortage of amoxicillin powder for oral suspension, the liquid form of the antibiotic that pediatricians use first for ear infections. Ear infections are "the most common indication for antibiotics in children," according to a research letter in Pediatrics¹ that dates the declaration to that day.

Prescribing changed almost overnight. At one Boston children's hospital system, the odds that a child with an ear infection left with an amoxicillin prescription fell by 91 percent after the declaration, the same letter found, while prescriptions for broader antibiotics jumped.

Demand, rather than a plant shutdown, drove this shortage, which left FDA with few levers. The agency cannot order companies to make more, and drugmakers did not have to warn it that demand was outrunning supply. FDA's own documents, three published studies and the federal government's survey of what pharmacies pay trace how it unfolded. It is the outpatient counterpart to our look at pediatric drug shortages in hospitals.

What FDA said caused it

FDA's report to Congress for calendar year 2022⁴ put the cause plainly. "During the COVID-19 public health emergency and the recent confluence of respiratory illnesses, including COVID-19, RSV, and seasonal influenza occurring at the same time, there have been substantial increases in demand for many products needed to treat patients, resulting in shortages of some of these products, such as amoxicillin oral suspension," the report said.

FDA's November 2022 compounding guidance⁶ said FDA "has received a number of reports related to increased demand for amoxicillin oral antibiotic suspension products in particular," and noted that amoxicillin "is widely used for the treatment of bacterial upper and lower respiratory infections in the pediatric population." Manufacturers said less. The Pediatrics letter reported that most of them "did not disclose a reason for the shortage or resolution timeframe."

Demand shortages are a blind spot in the law. FDA's report for 2023⁵ stated that "manufacturers are not required to notify FDA about shortages related to increases in demand, and this hampers FDA efforts to prevent or mitigate them." Its shortage FAQ⁸ adds that "FDA can't require firms to increase production." Our explainers on why drug shortages happen and why antibiotics keep running short cover the more common supply-side causes.

What FDA did

FDA's main step was to relax a rule for the traditional pharmacy compounding described in our piece on 503A and 503B pharmacies. In November 2022 it issued Compounding Certain Beta-Lactam Products in Shortage Under Section 503A⁶ as an immediately-in-effect guidance, skipping the usual comment period because of "the public health need for amoxicillin oral antibiotic suspension products." A notice of its availability ran in the Federal Register on Nov. 23, 2022⁷.

FDA normally treats preparing beta-lactam drugs, the penicillin family that includes amoxicillin, without complete separation from other products as an insanitary condition, because cross-contamination can trigger life-threatening allergic reactions. The guidance said that while these suspensions were on the shortage list, FDA would focus its enforcement on state-licensed pharmacies that prepared them without that separation and also skipped a set of minimum steps to limit cross-contamination. FDA justified the change by warning that the shortage "could lead to potentially serious or life-threatening situations in particular in the pediatric population, especially during the upcoming fall and winter months."

How prescribing shifted

In the Pediatrics study, researchers looked at children under 18 diagnosed with ear infections between May 15, 2022, and April 14, 2023. After Oct. 28, the odds of an amoxicillin prescription fell to about a tenth of the earlier level (an odds ratio of 0.09). The odds of amoxicillin-clavulanate rose nearly eightfold (an odds ratio of 7.9) and of cefdinir about ninefold. Managing the infection without antibiotics did not change significantly. By the end of the study period, the authors wrote, prescribing "approached pre-shortage levels." They also noted that national pediatric guidance during the shortage had pointed clinicians to alternatives, including other dosage forms, second-line drugs and watchful waiting.

A larger study in the Journal of the Pediatric Infectious Diseases Society² used data from emergency departments at seven children's hospitals between July 24, 2022, and April 1, 2023. Amoxicillin suspension prescribing had been rising in the weeks before the declaration. Then it dropped immediately by 30.8 percent. Use of amoxicillin in non-liquid forms rose 7.9 percent, amoxicillin-clavulanate 13.7 percent, cefdinir 6.4 percent and cephalexin 3.4 percent. The authors checked the same date in 2021 and 2023 and found no similar drop, and seven-day return visits were about the same before and after (1.3 percent and 1.2 percent).

A third study, in the American Journal of Infection Control³, compared 22 institutions' outpatient prescribing for respiratory illness in children before the shortage (January 2019 to September 2022) and during it (October 2022 to March 2023). Antibiotic prescribing for those illnesses rose, but the share going to amoxicillin fell, with wide variation between and within institutions.

What pharmacies paid

CMS's National Average Drug Acquisition Cost survey, or NADAC, tracks what retail pharmacies pay to buy drugs. GxRadar pulled the generic NADAC rows for two strengths of amoxicillin suspension from the CMS files for 2022⁹, 2023¹⁰ and later years through the 2026 file¹¹, and averaged the weekly figures by month. The capsule figures come from our amoxicillin drug page. These are approximate national benchmarks of pharmacy acquisition cost and say nothing about any patient's price.

Source: GxRadar analysis of CMS NADAC files via data.medicaid.gov; monthly averages of weekly generic rows.

The 400 mg/5 mL suspension was essentially flat in the year before the declaration, then rose 45 percent between October 2022 and January 2024. The 250 mg/5 mL strength rose 29 percent and the capsule 44 percent over the same span. Capsules have since come most of the way back, to 7.9 cents in October 2026, though they still cost pharmacies more than in 2014, which puts amoxicillin on our list of generics that got more expensive. The 400 mg/5 mL suspension has not; in October 2026 it was still 41 percent above its level when the shortage began. Our price pages carry NADAC histories for 47 generics.

Where it stands

Amoxicillin oral suspension does not appear anywhere in the openFDA shortage data¹² behind our shortage tracker, which as of Oct. 30, 2026, held 69 current shortages and 161 drugs to be discontinued. FDA treats a shortage as resolved when it determines that "supply is no longer exceeded by demand or projected demand," according to its FAQ⁸. GxRadar could not find a resolution date on FDA's public pages and has left one out. FDA's 2022 report argued that "with advance notice of increases in demand," the agency "may be able to take proactive steps." As of its report for 2023, drugmakers still had no obligation to give it.