The 2023 cancer drug shortage, from one plant to most US cancer centers

On Feb. 10, 2023, FDA announced a national shortage of cisplatin¹, a generic chemotherapy drug that has been in use for decades. Carboplatin, its close relative, joined FDA's shortage list on April 28. By the last week of May, 93 percent of the cancer centers that answered a National Comprehensive Cancer Network survey⁵ were short of carboplatin and 70 percent were short of cisplatin.

Both drugs are old and inexpensive, and both are the backbone of first-line treatment for several common cancers, including lung, bladder, ovarian, head and neck, and uterine cancers. For months in 2023, oncologists rationed doses, reshuffled regimens and hunted for vials. Researchers later traced the shortage to the shutdown of a single manufacturing facility⁷ for quality control lapses.

What happened next shows how little slack the market for generic sterile injectables has, and how limited FDA's tools are once a shortage starts. It is also not entirely over. In FDA's shortage data as of Oct. 30, 2026, published through openFDA⁹, carboplatin injection was still listed as a current shortage, three and a half years after it was first posted. GxRadar's analysis of how long shortages last puts that persistence in context.

One plant, a thin market

The authors of a cohort study published in December 2024⁷ in the Journal of the National Cancer Institute describe the cause plainly, as the shutdown of a single pharmaceutical manufacturing facility for quality control lapses, and their references include the FDA warning letter that followed. Losing one plant should not empty a national market. It did here because the market for old sterile injectables runs with few producers and little spare capacity, a pattern documented in GxRadar's piece on why sterile injectables dominate shortage lists.

FDA's shortage FAQ² makes the general point about older sterile injectables. Fewer firms make them, a limited number of production lines can, and when one company has a problem, the others struggle to raise output quickly. How FDA inspections lead to findings like the ones behind this shutdown is covered in FDA inspections, 483s and warning letters.

How the shortage unfolded

Sources: FDA Roundup, June 28, 2024¹; FDA letters of May 24³ and June 26, 2023⁴; NCCN surveys of June⁵ and October 2023⁶; FDA shortage data via openFDA⁹. Current status for both drugs is on the GxRadar shortage tracker.

What cancer centers reported

NCCN, a nonprofit alliance of US cancer centers, ran its first rapid survey from May 23 to 31, 2023. Of 27 responding member institutions, 93 percent reported a carboplatin shortage⁵ and 70 percent a cisplatin shortage.

Centers were coping, unevenly. All of them said they could still treat patients who needed cisplatin without delays or claim denials. Carboplatin was harder. Only 64 percent could keep every current patient on a carboplatin regimen, another 20 percent could continue it for some patients but not all, and 16 percent reported treatment delays because modified regimens needed new prior authorization.

By September the picture had improved only slightly. In the follow-up survey⁶, 72 percent of 29 responding centers still reported a carboplatin shortage and 59 percent a cisplatin shortage. The problem had also spread. Eighty-six percent of centers were short on at least one anti-cancer drug, including methotrexate (66 percent), 5-fluorouracil (55 percent) and fludarabine (45 percent), and 41 percent reported a hydrocortisone shortage. Methotrexate injection, first posted on March 13, 2023, also remained on FDA's current list in October 2026, according to the openFDA data⁹.

What changed for patients

Two later studies used real-world data to measure the effect on treatment.

A retrospective cohort study⁷ of 11,797 adults starting first-line treatment for advanced lung, head and neck, bladder, ovarian or uterine cancer compared the year before the shortage with the year after FDA announced it. Platinum use fell modestly across the full period. At the peak, in June 2023, adjusted platinum use was 57.8 percent, against 72.9 percent in June 2022, a drop of 15.1 percentage points. The authors found no difference in mortality between the two periods, with a median follow-up of 7.6 months, and noted that longer follow-up would be needed.

A claims-based study in JAMA Oncology⁸, published in October 2025, of 2,839 patients with newly diagnosed lung cancer looked at what replaced carboplatin. After the carboplatin shortage began, carboplatin use in metastatic lung cancer dropped immediately by 15.7 percentage points, and immunotherapy given without platinum rose by 18.4 points. In nonmetastatic disease, clinicians shifted between the two platinum drugs while total platinum use held steady.

How FDA responded

FDA cannot require a company to make a drug, to make more of it, or to keep making one it wants to discontinue, as its shortage FAQ² explains. Its tools are indirect, as GxRadar's explainer on how FDA works to prevent shortages details, and in 2023 it used several of them.

Temporary importation

Its most visible step was letting in cisplatin made for another market. FDA temporarily exercised discretion not to enforce the usual importation requirements, and its 2024 roundup¹ says the product and manufacturing sites were evaluated first. The imported product was not FDA-approved.

Letters sent to clinicians in May³ and June 2023⁴ spelled out the practical differences. The vials and cartons were labeled in Chinese, and stickers were added with the product name, strength, US NDC number, the Rx-only statement and the standard dose warning. The letters warned that the original linear barcode might not register accurately on US scanning systems and supplied a scannable replacement. GxRadar's NDC explainer covers why that code matters in hospital systems.

Those letters flagged other gaps as well. Cartons lacked the serialized product identifier required under the Drug Supply Chain Security Act, and the foreign labeling listed routes of administration and dosing regimens that differ from the US label, which is for intravenous use only. The letters also stated that the ingredients were essentially the same as the US product.

Rebuilding approved supply

According to the June 28, 2024, roundup¹, FDA worked closely with five cancer drug manufacturers to raise production, helped a manufacturer that had stopped making an approved cisplatin product return to the market, and later approved the manufacturer whose product had first come in under temporary importation. That brought the number of approved cisplatin manufacturers to seven, and FDA declared the national cisplatin shortage over.

Why it could happen again

None of the underlying economics changed. Platinum chemotherapy is still old, still generic and still cheap, and sterile injectable lines still take years and large capital to build or expand. When a single site supplies a large share of a molecule, an inspection finding at that site becomes a national event. GxRadar's piece on why drug shortages happen covers the wider causes.

Temporary importation helps, but it brings foreign labeling, barcode and traceability gaps into hospital pharmacies, and it depends on finding an overseas maker with spare capacity and a product FDA is willing to accept.

Carboplatin's entry is the one to watch. In the October 2026 data⁹, one listing for the drug still showed limited supply, a manufacturing delay and an estimated recovery date of December 2026.