Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manuf...

FDA Drug Recall #D-0766-2022 — Class III — April 5, 2022

Recall Summary

Recall Number D-0766-2022
Classification Class III — Low risk
Date Initiated April 5, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aurobindo Pharma USA Inc.
Location East Windsor, NJ
Product Type Drugs
Quantity 433,809 vials

Product Description

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

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.

Other Recalls from Aurobindo Pharma USA Inc.

Recall # Classification Product Date
D-0492-2024 Class II Clorazepate Dipotassium Tablets, USP, 7.5 mg, a... Apr 24, 2024
D-0491-2024 Class II Clorazepate Dipotassium Tablets, USP, 3.75 mg, ... Apr 24, 2024
D-1171-2023 Class II Rasagiline Tablets 0.5mg, 30-count bottle, Rx o... Aug 2, 2023
D-1087-2023 Class II Rufinamide Tablets, USP 200 mg, packaged in 120... Jul 21, 2023
D-1088-2023 Class II Rufinamide Tablets, USP 400 mg, packaged in 120... Jul 21, 2023

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.