Which drug manufacturers have the most FDA recalls? (2026 data)
Drug recalls are one of the clearest, most objective safety signals a manufacturer leaves behind. We analyzed the FDA enforcement (recall) history behind every company in the pharmaranks catalog to answer a question no official source ranks: which drug manufacturers have the worst recall record?
How we measured this
Every company on pharmaranks carries a 0–5 recall-safety score from its FDA enforcement history (openFDA), where a lower score means a heavier recall record. We took every manufacturer with at least 10 rated products, consolidated the FDA's separate registered entities into a single parent maker, and computed each maker's product-weighted average. The result covers 46 manufacturers; the average score is 3.4 / 5.
Manufacturers with the heaviest recall record
| Rank | Manufacturer | Recall-safety score (0–5) | Rated products |
|---|---|---|---|
| 1 | Teva | 2.3 | 46 |
| 2 | Hospira | 2.7 | 72 |
| 3 | Pfizer | 2.8 | 122 |
| 4 | Lupin | 2.8 | 20 |
| 5 | Mylan | 3.1 | 29 |
| 6 | Fresenius | 3.1 | 39 |
| 7 | Apotex | 3.1 | 23 |
| 8 | Aurobindo | 3.2 | 32 |
| 9 | Sandoz | 3.2 | 54 |
| 10 | Novartis | 3.4 | 126 |
| 11 | Viatris | 3.4 | 18 |
| 12 | Emd | 3.5 | 17 |
What the data shows
The bottom of the table is dominated by high-volume generic and sterile-injectable makers like Teva, Hospira, Pfizer, Lupin. Recall frequency rises with the number of products and batches a company ships, so a low score flags a heavier recall history — not that a company's drugs are unsafe to take. Every recalled lot is, by definition, pulled from the market.
How to read this responsibly
- Recall frequency is not overall quality. A large generics maker logs more recalls than a small specialty firm even at the same defect rate.
- A recall is the system working — a problem was caught and the product removed.
- Not medical or investment advice. Don't stop a medication based on this page; talk to your pharmacist or prescriber.
Check any company on the companies directory; see the method on how we rate.
Figures are generated live from the pharmaranks database (FDA openFDA enforcement data) at publication time.
This article is for general education and is not medical advice. Consult a licensed professional for guidance about your health.