CLASS III Drug recall · Reported 9 Jun 2021 · FDA Enforcement Report
Thiamine HCl Injection, USP 200 mg/ (100mg/mL) vials recalled
Mylan Institutional is recalling Thiamine HCl Injection, USP 200 mg/ (100mg/mL) vials, distributed nationwide in the US. The recall was initiated on 3 May 2021 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-0601-2021
- FDA event ID
- 87803
- Recalling firm
- Mylan Institutional, Rockford, IL
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 May 2021
- FDA classified
- 1 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 3 May 2021 | Recall initiated by company | |
| 1 Jun 2021 | Classified by FDA | +29 days |
| 9 Jun 2021 | 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
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Which lots are affected?
Lot #: 200906, Exp. Date February 2022
Where was it sold?
Nationwide within the United States
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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Thiamine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection recalled | AnazaoHealth | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 200 mg/ (100mg/mL), Riboflavin 2 mg recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine/ribofla/niacinami/dexpanth/pyridox/hydroxycobal recalled | Pharmacy Innovations | Sterility | Nationwide |