Why medicines get contaminated
pharmaranks analyzed 881 US drug recalls caused by contamination or impurity, from Jan 2, 2024 to Jun 22, 2026.
What kind of contamination
Every recall here was pulled for a contamination or impurity reason. The count in grey is how many of that kind reached Class I— the FDA’s label for a defect that could cause serious harm or death.
The single largest cause is microbial contamination and loss of sterility — 328 recalls, and it accounts for 27 of the Class I cases on this page. Sterility matters most for the things that bypass the gut: injectables, eye drops, and inhalation products, where a contaminant reaches the bloodstream, the eye, or the lung directly.
The nitrosamine story, by the numbers
Nitrosamines (NDMA, NDEA) are probable human carcinogens that turned up as manufacturing by-products in several common generics from 2018 on — the recalls that pulled valsartan, then metformin and ranitidine. This dataset holds the most recent 8 such recalls:
| Product | Manufacturer | Class | Started |
|---|---|---|---|
| Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceutica | Asclemed USA Inc. | Class II | May 14, 2026 |
| Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Bi | Appco Pharma LLC | Class II | Mar 27, 2026 |
| Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: B | Appco Pharma LLC | Class II | Mar 27, 2026 |
| Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Bi | Appco Pharma LLC | Class II | Mar 27, 2026 |
| Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: | Cipla USA, Inc. | Class II | Nov 14, 2025 |
| Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: | Cipla USA, Inc. | Class II | Nov 14, 2025 |
| Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: | Cipla USA, Inc. | Class II | Nov 14, 2025 |
| clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 167 | Zydus Pharmaceuticals (USA) Inc | Class II | Oct 22, 2025 |
When these recalls happened
Who was recalled most
Manufacturers with the most contamination or impurity recalls in this window. A high count is not a verdict on a company — a large generic maker ships more products, so it has more to recall — but it is a fact from the public record.
Methodology & sources
Built from the openFDA drug Enforcement (recall) database, the FDA’s own record of every drug recall. We selected the 881recalls whose stated reason names a contamination or impurity, and grouped them by the kind of contamination using the reason text. “Class I” is the FDA’s classification for a defect that could cause serious harm or death. Counts are recall events, not units. The full underlying data is downloadable as CSV. This is public regulatory data, not medical advice.
See also the broader FDA Drug Recall Report and the latest recalls tracker.