CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Methylcobolamin 6500 mcg/, 1000 mcg/, 5000mcg/mL, 3000mcg recalled
Fallon Wellness Pharmacy is recalling Methylcobolamin 6500 mcg/, 1000 mcg/, 5000mcg/mL, 3000mcg/, 4000mcg/, 1000mcg/mL and 1000, distributed in New York. The recall was initiated on 17 Mar 2015 and the FDA has classified it as Class II.
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-1074-2015
- FDA event ID
- 70807
- Recalling firm
- Fallon Wellness Pharmacy, Latham, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2015
- FDA classified
- 12 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Mar 2015 | Recall initiated by company | |
| 12 May 2015 | Classified by FDA | +56 days |
| 20 May 2015 | 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
Lack of assurance of sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Where it was distributed
New York
Questions about this recall
Is Methylcobolamin 6500 mcg/, 1000 mcg/, 5000mcg/mL, 3000mcg/, 4000mcg/, 1000mcg/mL and 1000 recalled?
Yes. Fallon Wellness Pharmacy recalled Methylcobolamin 6500 mcg/, 1000 mcg/, 5000mcg/mL, 3000mcg/, 4000mcg/, 1000mcg/mL and 1000 on 17 Mar 2015. The recall is Class II and its status is Terminated. Recall number D-1074-2015.
Why was it recalled?
Lack of assurance of sterility
Which lots are affected?
Lot#: a) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15
Where was it sold?
New York
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.