Why does an imported shortage drug have a foreign label, and how do I read it safely?
During some shortages of medically necessary drugs, the FDA may look for a registered foreign manufacturer willing to redirect foreign-approved product into the US market. Our reading: product approved for another market can arrive with labeling written for that market. Any translations, added labels or letters that come with it are new text, often written quickly, so a correctly spelled wrong word there lands where clinicians are relying on it.
This page is general information, not legal or regulatory advice.
Why imported shortage drugs have foreign labels
The FDA's drug shortages FAQ says that when US manufacturers can't resolve a shortage immediately and the shortage involves a medically necessary drug, the FDA may look for an FDA-registered foreign manufacturer that is willing and able to redirect foreign-approved product into the US market. The FDA says it requests and evaluates information such as the formulation and the quality of the manufacturing site, and its Drug Shortages Staff determines when the non-US approved product is no longer needed.
Where wording errors can enter
Our view: each piece is new text. Translations, added English labels and any letter that explains the product are often prepared fast, and each is a copy of information that already exists in another language.
Made-up example: a translated comparison chart should say "hypotension" in an adverse-reaction row, but it says "hypertension". The original-language label is correct, and a reader relying on the translation gets the opposite condition.
Why spellcheck misses it
Both words are real and spelled correctly, so spellcheck passes them. A check that any letter or added labels are present won't catch a word swap inside them.
How to read these safely
Practice advice:
- If a letter or notice comes with the product, read the one for the specific product you received.
- Read any translations or comparison tables for meaning, especially dosing, warnings and administration lines.
- Check that added English labels say the same thing as the material that explains them.
- If something doesn't make sense, stop and check before use. See a medicine label looks wrong: what to do.
- For translated labels generally, see bilingual and translated drug labels.
This is our reading of public guidance, not legal or regulatory advice.
Sources
Last reviewed: October 18, 2026
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FAQ
Why does an imported drug have a foreign label?
During some shortages of medically necessary drugs, the FDA may look for a registered foreign manufacturer to redirect foreign-approved product into the US market. Our reading is that such product can carry labeling written for its original market.
How do I read a drug label that isn't the US-approved version?
Practice advice: read any letter or translation that comes with that specific product, and read dosing, warnings and administration lines for meaning.
Can translated over-labels on imported drugs introduce wrong words?
Yes. Any new translation or added label can carry a correctly spelled wrong word, so read it for meaning.