BAYSHORE PHARMACEUTICALS recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco
BAYSHORE PHARMACEUTICALS recalls 750mg Metformin Extended-Release Tablets due to CGMP deviations. This may affect safety in manufacturing. Check NDC 76385-129-01 and lot #18657.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
BAYSHORE PHARMACEUTICALS is recalling 750mg Metformin Hydrochloride Extended-Release Tablets (Rx only) because of manufacturing quality control issues. This recall affects people who have these specific tablets and may pose safety risks due to potential deviations in production standards. Read more at govinfonow.com/recall/36827-bayshore-metformin-tablets-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36827-bayshore-metformin-tablets-recall-cgmp-deviations-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1544-2020
Cite this page
“BAYSHORE Metformin Tablets Recall: CGMP Deviations Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36827-bayshore-metformin-tablets-recall-cgmp-deviations-risk. Based on FDA recall #D-1544-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1544-2020%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in manufacturing quality control processes. This could mean the tablets might not meet safety standards, potentially leading to health risks if used improperly. However, the exact nature of the deviation isn't specified in the recall notice.
Who’s affected
People who have the specific 750mg Metformin Extended-Release Tablets with NDC 76385-129-01 and lot #18657. Those using prescription diabetes medication are most at risk.
How to tell if you have this one
Check for the NDC code 76385-129-01 and lot number 18657 on the packaging. These tablets are prescription-only and manufactured by Beximco Pharmaceuticals in Bangladesh.
- Brand
BAYSHORE PHARMACEUTICALS- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
nationwide- NDC
76385-128-10, 76385-128-01, 76385-128-50, 76385-129-01, 76385-129-50
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1543-2020 | 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; Lot #18641; Exp. 05/2021 | 594 bottles |
| D-1544-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01; Lot #18657, Exp. 05/2021 | 3984 bottles |
What to do — step by step
Check Product Details
Look for NDC 76385-129-01 and lot #18657 on the packaging to confirm if the product is recalled.
Questions people ask
Why is this product being recalled?
The recall is due to CGMP deviations, which are manufacturing quality control issues. The exact nature of the deviation isn't specified in the notice.
How do I know if I have the recalled product?
Check for NDC 76385-129-01 and lot #18657 on the packaging. These tablets are prescription-only and manufactured by Beximco Pharmaceuticals in Bangladesh.
What should I do if I have the recalled product?
The recall notice does not specify a remedy or action steps for affected products.
Contact BAYSHORE PHARMACEUTICALS
We’ve drafted a message you can send BAYSHORE PHARMACEUTICALS to request your refund or repair — edit it as you like.
Subject: Recall D-1544-2020 — BAYSHORE PHARMACEUTICALS BAYSHORE PHARMACEUTICALS Hello, I own a BAYSHORE PHARMACEUTICALS that is covered by recall D-1544-2020 from BAYSHORE PHARMACEUTICALS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1544-2020 (August 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1544-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.