Chiesi recall: Revcovi
Chiesi USA, Inc. is recalling Revcovi – 3,002 vials. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 19, 2026. Distributed in 2 states (Missouri, Tennessee).
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Revcovi |
| Brand | Chiesi |
| Company | Chiesi USA, Inc. |
| Type | Drugs |
| Classification | Class III |
| Recall date | August 19, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 3,002 vials |
| Recall ID | 99705 |
Recalled products
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
- FDA recall number
- D-0838-2026
- Codes, lots and dates
- Lot#: 1221973, Exp 3/24/2027
- Quantity
- 3,002 vials
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99705
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Cary, NC, United States
Why it was recalled
The reason the FDA lists: “Failed Stability Specifications: Out of specification stability result for the protein concentration profile.”
Where it was sold
2 states: Missouri, Tennessee. Distribution as the FDA records it: “MO, TN”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99705, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
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| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Chiesi Revcovi recalled?
Yes. Chiesi USA, Inc. recalled it on August 19, 2026; FDA published it September 9, 2026 (Class III). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
In 2 states (Missouri, Tennessee).
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.