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 — they are issued by the U.S. FDA, logged publicly, and tied to real quality or contamination problems. We analyzed the FDA enforcement (recall) history behind every company in the pharmaranks catalog to answer a simple question: which drug manufacturers have the worst recall record?

How we measured this

Every company on pharmaranks carries a 0–5 recall-safety score derived from its FDA enforcement history (openFDA), where a lower score means a heavier recall record. For this analysis we:

• took every manufacturer with a recall-safety score and at least 10 rated products,
• consolidated the FDA's separate registered entities (e.g. "Teva" and "Teva Pharms USA") into a single parent maker, and
• computed each maker's product-weighted average score.

The result covers 47 manufacturers. The average recall-safety score across them 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	Lupin	2.8	20
4	Pfizer	2.8	122
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	Bayer	3.4	17
12	Viatris	3.4	18

What the data shows

The bottom of the table is dominated by high-volume generic and sterile-injectable makers — companies like Teva, Hospira, Lupin, Pfizer. This is an important nuance: these manufacturers produce enormous volumes of low-margin generic and injectable products, and recall frequency rises with the number of products and batches a company ships. A low recall-safety 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.

By contrast, the makers with the cleanest recall records in our data are Mallinckrodt (3.6), Mayne (3.6), Haleon (3.6), Impax (3.6), Merck (3.6).

How to read this responsibly

• Recall frequency is not the same as overall quality. A large generics maker shipping thousands of products will almost always log more recalls than a small specialty firm, even at the same defect rate.
• A recall is the system working. It means a problem was caught and the product removed.
• This is not medical or investment advice. If you take a medication from any manufacturer, do not stop based on this page — talk to your pharmacist or prescriber.

Want to check a specific company? Every manufacturer has its own page with its score, product list, and source breakdown — browse them all on the companies directory, and see exactly how the score is built on the how we rate page.

Figures are generated live from the pharmaranks database (FDA openFDA enforcement data) and reflect the catalog at the time of publication.