Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Take action
Contact the company
📍Recalling firmGenentech Inc1 Dna Way · South San Francisco, CA 94080-4918
“Genentech Evrysdi Oral Solution Recall: Incorrect Bottle Adapter Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36204-genentech-evrysdi-oral-solution-recall-incorrect-bottle-adapter-risk. Based on FDA recall #D-0357-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0357-2021%22&limit=1).
The FDA announced on April 20, 2021, that Genentech Inc. is recalling Evrysdi (risdiplam) for oral solution due to defective press-in-bottle adapters. The company initiated this voluntary Class III recall after receiving complaints about the incorrect components.
How to tell if you have it
Brand: Genentech
Product: Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only
NDC: 50242-175-05
Lot codes: B1001B05, B1001B08
Expiration date: Feb-2022
Quantity: 2,627 bottles
Distribution: Nationwide in the USA
The hazard
The recall addresses defective press-in-bottle adapters (PIBA) that have a female fit instead of the required male fit. This defect prevents the product from being used in combination with co-packed syringes, according to the FDA.
Context
GovInfoNow's records show Genentech, Inc. has 9 other recalls on record since July 30, 2012. Other recent recalls of similar products include Hikma Alendronate Sodium Oral Solution Recall (April 7, 2026), Winder Morphine Sulfate Oral Solution Recall (Nov. 26, 2025), and Synjardy XR Tablets Recall (June 12, 2026).
How to tell if you have this one
Check for the bottle label with NDC 50242-175-05 and lot numbers B1001B05 or B1001B08. The product was distributed with an expiration date of February 2022.
Brand
Genentech
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Bottle Adapter
Ensure the bottle adapter is male-fitting to connect with syringes; if female, it may not work properly.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The product is safe if the adapter is correctly fitted. However, the recalled bottles have a female adapter that may not connect with syringes, so check the adapter type before use.
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-0357-2021 (April 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0357-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.