CLASS III Drug recall · Reported 20 Apr 2022 · FDA Enforcement Report
Cyanocobalamin Injection, USP, 1,000 mcg per mL recalled
Aurobindo Pharma USA is recalling Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only Vial, distributed nationwide in the US. The recall was initiated on 5 Apr 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0766-2022
- FDA event ID
- 89941
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Cyanocobalamin
- Manufacturer
- AuroMedics Pharma LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Apr 2022
- FDA classified
- 12 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Apr 2022 | Recall initiated by company | |
| 12 Apr 2022 | Classified by FDA | +7 days |
| 20 Apr 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of Specification results for Assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of Specification results for Assay
Which lots are affected?
Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Cyanocobalamin recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalled | Zydus Pharmaceuticals | Particulate Matter | TN |
| Drug | CLASS II | Cyanocobalamin 2 mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |