Pfizer Cytotec Tablets Recall: Impurities May Cause Harm
Pfizer recalls Cytotec misoprostol tablets due to impurities and degradation products found in some lots. These tablets are for institutional use only and require a prescription.
Recall notice
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Contact the company
What happened, in plain English
Pfizer is recalling Cytotec misoprostol tablets that may contain impurities and degradation products. This could pose a risk to users, especially since these tablets are for institutional use only and require a prescription. Read more at govinfonow.com/recall/42450-pfizer-cytotec-tablets-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/42450-pfizer-cytotec-tablets-recall-impurities-may-cause-harm · Updated October 9, 2026 · FDA enforcement record: FDA #D-0424-2017
Cite this page
“Pfizer Cytotec Tablets Recall: Impurities May Cause Harm.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42450-pfizer-cytotec-tablets-recall-impurities-may-cause-harm. Based on FDA recall #D-0424-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0424-2017%22&limit=1).
Why it’s dangerous
The tablets may contain impurities and degradation products that could be harmful. These issues were detected after 18 months of storage, which could affect safety for users.
Who’s affected
People who have prescription Cytotec misoprostol tablets from Pfizer for institutional use. Those using these tablets for medical purposes under supervision are most at risk.
How to tell if you have this one
Check for the product name 'Cytotec' with 200 mcg tablets in a 100-tablet blister pack (10X10). Look for lot numbers B08493 (expires 12/2016) or B13230 (expires 08/2018).
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the blister pack to determine if your tablets are in the recalled lots.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0424-2017 (September 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0424-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.