CLASS III Drug recall · Reported 13 Jan 2016 · FDA Enforcement Report
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in container recalled
Freedom Pharmaceuticals is recalling 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in container, distributed nationwide in the US. The recall was initiated on 8 Jan 2015 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-0562-2016
- FDA event ID
- 72797
- Recalling firm
- Freedom Pharmaceuticals, Broken Arrow, OK
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Jan 2015
- FDA classified
- 6 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 8 Jan 2015 | Recall initiated by company | |
| 6 Jan 2016 | Classified by FDA | +363 days |
| 13 Jan 2016 | Published in enforcement report | +7 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
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
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot# F11641, Exp 9/17/2016
Where was it sold?
Nationwide
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 Freedom Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Baclofen USP powder recalled by Freedom Pharmaceuticals | Freedom Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Domperidone BP, Active Pharmaceutical Ingredient recalled | Freedom Pharmaceuticals | Packaging Defects | Nationwide |