Cyanocobalamin Injection — Class III drug recall D-0766-2022
Terminated recall by Aurobindo Pharma USA Inc., reported 2022-04-20, distributed nationwide. Subpotent Drug: Out of Specification results for Assay
| Recall number | D-0766-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2022-04-05 |
| Classified | 2022-04-12 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 433,809 vials |
| Reason classes | potency, specification failure |
| NDC | 55150-0364, 55150-0364-01, 55150-0364-10, 55150-0364-25 |
| Lot numbers | CCC210004, CCC210005, CCC210006, CCC210007, CCC210010, CCC210011 |
| Expiration dates | 2022-09, 2022-11, 2023-04 |
Product
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Reason for recall
Subpotent Drug: Out of Specification results for Assay
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0766-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.