CLASS II Drug recall · Reported 14 May 2014 · FDA Enforcement Report
Metformin Hydrochloride Tablets USP 1000 mg recalled
Blu Pharmaceuticals is recalling Metformin Hydrochloride Tablets USP 1000 mg, distributed in Connecticut, Illinois, New Jersey, Utah. The recall was initiated on 13 Mar 2014 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-1302-2014
- FDA event ID
- 67739
- Recalling firm
- Blu Pharmaceuticals, Franklin, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2014
- FDA classified
- 5 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 13 Mar 2014 | Recall initiated by company | |
| 5 May 2014 | Classified by FDA | +53 days |
| 14 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: Product distributed without inner seal on bottles.
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
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
Where it was distributed
NJ, UT, IL and CT
Questions about this recall
Is Metformin Hydrochloride Tablets USP 1000 mg recalled?
Yes. Blu Pharmaceuticals recalled Metformin Hydrochloride Tablets USP 1000 mg on 13 Mar 2014. The recall is Class II and its status is Terminated. Recall number D-1302-2014.
Why was it recalled?
Defective container: Product distributed without inner seal on bottles.
Which lots are affected?
Lot # 13E0014F1P8V; Exp. 04/15
Where was it sold?
NJ, UT, IL and CT
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.
More recalls from Blu Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Tablets USP 500 mg recalled | Blu Pharmaceuticals | Packaging Defects | 4 states |
Other Metformin recalls
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | Nationwide |