CLASS II Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg recalled
Bayshore Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, distributed nationwide in the US. The recall was initiated on 19 Aug 2020 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-1543-2020
- FDA event ID
- 86280
- Recalling firm
- Bayshore Pharmaceuticals, Short Hills, NJ
- Manufacturer
- UNICHEM PHARMACEUTICALS (USA), INC.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2020
- FDA classified
- 25 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 19 Aug 2020 | Recall initiated by company | |
| 25 Aug 2020 | Classified by FDA | +6 days |
| 2 Sep 2020 | 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
CGMP Deviations
Product as listed by the FDA
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #18641; Exp. 05/2021
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 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 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.
Other products in this recall event
1 other product · FDA event 86280This product is part of a recall event; the main page for the event is Metformin Hydrochloride Extended-Release Tablets USP, 750 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg recalledMetformin Hydrochloride | Bayshore Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Bayshore Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg recalledMetformin Hydrochloride | Bayshore Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., USA | 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, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| 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 |