Quick answers
- What is Metformin hydrochloride used for?
- The FDA-approved label (Metformin hydrochloride, Oceanside Pharmaceuticals, November 14, 2024) says: “Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metformin hydrochloride have a boxed warning?
- Yes. The FDA label for Metformin hydrochloride has a boxed warning (“WARNING: LACTIC ACIDOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Metformin hydrochloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 22, 2026). Ask your pharmacist about alternatives.
- Has Metformin hydrochloride been recalled?
- FDA enforcement reports list 30 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Metformin hydrochloride?
- 74 companies list prescription products of Metformin hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Aphena Pharma Solutions - Tennessee, LLC.
What Metformin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
— FDA label: Metformin hydrochloride, Oceanside Pharmaceuticals, effective November 14, 2024. Read the full label on DailyMed →
The FDA has 285 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LACTIC ACIDOSIS
. Read it on the full label →
246 of 285 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet · Tablet, film coated · Tablet, film coated, extended release · Tablet, coated · Solution |
|---|---|
| Route | Oral |
| Prescription products | 450 in the FDA NDC Directory |
| Brand names | Glumetza |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| metformin hydrochloride 1000 mg tablet | Generic | $0.0233 per tablet |
| metformin hydrochloride 1000 mg tablet, coated | Generic | $0.0233 per tablet |
| metformin hydrochloride 1000 mg tablet, extended release | Generic | $0.3116–$0.3371 per tablet 7 packages, lowest to highest |
| metformin hydrochloride 1000 mg tablet, film coated | Generic | $0.0233 per tablet |
| metformin hydrochloride 1000 mg tablet, film coated, extended release | Generic | $0.3116–$0.3371 per tablet 7 packages, lowest to highest |
| metformin hydrochloride 500 mg tablet | Generic | $0.0148–$0.0284 per tablet 20 packages, lowest to highest |
| metformin hydrochloride 500 mg tablet, coated | Generic | $0.0148 per tablet |
| metformin hydrochloride 500 mg tablet, extended release | Generic | $0.0284–$0.2831 per tablet 36 packages, lowest to highest |
| metformin hydrochloride 500 mg tablet, film coated | Generic | $0.0148 per tablet |
| metformin hydrochloride 500 mg tablet, film coated, extended release | Generic | $0.1891–$0.2831 per tablet 7 packages, lowest to highest |
| metformin hydrochloride 500 mg/5 mL solution | Generic | $0.3589 per mL |
| metformin hydrochloride 625 mg tablet | Generic | $12.53 per tablet |
| metformin hydrochloride 750 mg tablet | Generic | $0.0508–$14.61 per tablet 4 packages, lowest to highest |
| metformin hydrochloride 750 mg tablet, extended release | Generic | $0.0508 per tablet |
| metformin hydrochloride 850 mg tablet | Generic | $0.0244 per tablet |
| metformin hydrochloride 850 mg tablet, coated | Generic | $0.0244 per tablet |
| metformin hydrochloride 850 mg tablet, film coated | Generic | $0.0244 per tablet |
NADAC list of November 4, 2026; these prices took effect between February 25, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions56 products
- Bryant Ranch Prepack34 products
- Aphena Pharma Solutions - Tennessee, LLC24 products
- Proficient Rx LP20 products
- Remedyrepack Inc.19 products
- PD-Rx Pharmaceuticals, Inc.18 products
- NuCare Pharmaceuticals, Inc.15 products
- Preferred Pharmaceuticals Inc.15 products
- Ascend Laboratories, LLC12 products
- Northwind Health Company, LLC10 products
- Aurobindo Pharma Limited10 products
- Coupler LLC9 products
- ScieGen Pharmaceuticals, Inc.9 products
- Direct_Rx8 products
- Quallent Pharmaceuticals Health LLC8 products
- Westminster Pharmaceuticals, LLC8 products
- Granules Pharmaceuticals Inc.7 products
- Epic Pharma, LLC7 products
- Granules India Ltd7 products
- Macleods Pharmaceuticals Limited6 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Time Cap Laboratories, Inc5 products
- Zydus Lifesciences Limited5 products
- Chartwell RX, LLC5 products
- Precision Dose, Inc.5 products
- Mylan Pharmaceuticals Inc.5 products
- Marksans Pharma Limited5 products
- Laurus Labs Limited5 products
- QPharma, Inc.5 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Lupin Pharmaceuticals, Inc.4 products
- Legacy Pharmaceutical Packaging, LLC4 products
- Amneal Pharmaceuticals LLC4 products
- Ajanta Pharma USA Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals3 products
- Major Pharmaceuticals3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Unit Dose Solutions, Inc.3 products
- Micro Labs Limited3 products
- Mullan Pharmaceutical Inc.3 products
- American Health Packaging3 products
- Amneal Pharmaceuticals of New York LLC3 products
- ACI Healthcare USA, Inc.3 products
- Santarus, Inc.3 products
- Metcure Pharmaceuticals, Inc.3 products
- Advanced Rx of Tennessee, LLC2 products
- AiPing Pharmaceutical, Inc.2 products
- Oceanside Pharmaceuticals2 products
- TAGI Pharma, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- AvPAK2 products
- Ingenus Pharmaceuticals, LLC2 products
- TruPharma, LLC2 products
- Method Pharmaceuticals, LLC2 products
- Viona Pharmaceuticals Inc2 products
- Marlex Pharmaceuticals, Inc.2 products
- AvKARE2 products
- Solco Healthcare US, LLC2 products
- Qingdao BAHEAL Pharmaceutical Co., Ltd.2 products
- VGYAAN Pharmaceuticals LLC2 products
- Lifsa Drugs LLC2 products
- Camber Pharmaceuticals, Inc.1 product
- Cardinal Health 107, LLC1 product
- NuCare Pharmaceuticcals, Inc.1 product
- Calvin Scott & Co., Inc.1 product
- VistaPharm, LLC1 product
- Leading Pharma, LLC1 product
- Bionpharma Inc.1 product
- Saptalis Pharmaceuticals, LLC.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- RedPharm Drug, Inc.1 product
- Redpharm Drug1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021748 GLUMETZA | Santarus Inc | June 3, 2005 | 9, latest August 11, 2026 2026: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (52)
- ANDA075972Chartwell · January 24, 2002
- ANDA075965Epic Pharma LLC · January 25, 2002
- ANDA075973Mylan · January 25, 2002
- ANDA077095Aurobindo · January 14, 2005
- ANDA077060Zydus Lifesciences · April 20, 2005
- ANDA077078Zydus Lifesciences · April 21, 2005
- ANDA077336Sun Pharm Inds (In) · February 9, 2006
- ANDA077880Amneal Pharms Ny · June 5, 2006
- ANDA076756Nostrum Pharms LLC · July 26, 2006
- ANDA078596Amneal Pharms Ny · January 3, 2008
- ANDA078321Cspc Ouyi · April 17, 2008
- ANDA090564Granules India · April 22, 2010
- ANDA091184Alkem · November 1, 2010
- ANDA090692Lupin Ltd · June 29, 2011
- ANDA201991Adaptis · January 18, 2012
- ANDA090888Pharmazone · March 12, 2012
- ANDA079118Aurobindo Pharma Ltd · July 20, 2012
- ANDA200690Mylan Pharms Inc · August 1, 2012
- ANDA091664Lupin · July 19, 2013
- ANDA203769Sciegen Pharms · September 11, 2013
- ANDA203686Zydus Hlthcare · August 28, 2014
- ANDA090295Pharmazone · April 29, 2016
- ANDA205096Cspc Ouyi · July 11, 2016
- ANDA206955Macleods Pharms · December 7, 2016
- ANDA207427Regcon Holdings · December 13, 2016
- ANDA202306Platinum · February 23, 2017
- ANDA205330Aarxion Anda Hlding · October 31, 2017
- ANDA203832Mpp Pharma · December 26, 2017
- ANDA209313Granules · March 16, 2018
- ANDA209882Laurus · August 27, 2018
- ANDA211052Yichang Humanwell · September 24, 2018
- ANDA206145Alkem Labs Ltd · October 22, 2018
- ANDA209674Novast Labs · November 2, 2018
- ANDA209993Qingdao Baheal Pharm · December 27, 2018
- ANDA212969Glenmark Pharms Ltd · November 25, 2019
- ANDA211309Saptalis Pharms · March 3, 2020
- ANDA213651Ajanta Pharma Ltd · April 9, 2020
- ANDA213344Granules · January 14, 2021
- ANDA213962Ajanta Pharma Ltd · March 9, 2021
- ANDA213334Sciegen Pharms · April 16, 2021
Showing the 40 earliest of 52.
Shortage status
To be discontinued · updated October 22, 2026 · first posted October 22, 2026
| Product | Metformin Hydrochloride, Tablet, Extended Release, 1000 mg (NDC 0378-6001-91) |
|---|---|
| Company | Mylan Pharmaceuticals Inc., a Viatris Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 13, 2025 · Class II · Ongoing · D-0328-2025
CGMP Deviations
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, M — Glenmark Pharmaceuticals Inc., USA
-
February 25, 2025 · Class II · Ongoing · D-0292-2025
Presence of Foreign Tablets/Capsules.
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. — A-S Medication Solutions LLC
-
December 30, 2024 · Class II · Terminated · D-0192-2025
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand — Granules Pharmaceuticals Inc.
-
December 27, 2021 · Class II · Terminated · D-0392-2022
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 — VIONA PHARMACEUTICALS INC
-
June 1, 2021 · Class II · Terminated · D-0640-2021
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01 — VIONA PHARMACEUTICALS INC
-
May 4, 2021 · Class II · Terminated · D-0372-2021
Presence of foreign substance: identified as activated carbon.
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Ha — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 25, 2021 · Class III · Terminated · D-0325-2021
Failed Moisture Limits: Out of specification for water content
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 12, 2020 · Class II · Terminated · D-0058-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90 — Direct Rx
-
October 6, 2020 · Class II · Terminated · D-0060-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60 — PD-Rx Pharmaceuticals, Inc.
-
October 6, 2020 · Class II · Terminated · D-0059-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Ok — PD-Rx Pharmaceuticals, Inc.
-
October 2, 2020 · Class II · Terminated · D-0062-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Phar — Marksans Pharma Limited
-
October 2, 2020 · Class II · Terminated · D-0061-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx — Marksans Pharma Limited
-
August 19, 2020 · Class II · Terminated · D-1544-2020
CGMP Deviations
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 — BAYSHORE PHARMACEUTICALS
-
August 19, 2020 · Class II · Terminated · D-1543-2020
CGMP Deviations
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 — BAYSHORE PHARMACEUTICALS
-
July 7, 2020 · Class II · Terminated · D-1382-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 — Lupin Pharmaceuticals Inc.
-
July 7, 2020 · Class II · Terminated · D-1385-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07 — Lupin Pharmaceuticals Inc.
-
July 7, 2020 · Class II · Terminated · D-1383-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09 — Lupin Pharmaceuticals Inc.
-
July 7, 2020 · Class II · Terminated · D-1384-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07 — Lupin Pharmaceuticals Inc.
-
July 3, 2020 · Class II · Ongoing · D-1386-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Gr — Granules Pharmaceuticals Inc
-
June 11, 2020 · Class II · Terminated · D-1334-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) — Lupin Pharmaceuticals Inc.
-
June 5, 2020 · Class II · Terminated · D-1356-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Ph — Marksans Pharma Limited
-
June 5, 2020 · Class II · Terminated · D-1333-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx — PD-Rx Pharmaceuticals, Inc.
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May 29, 2020 · Class II · Ongoing · D-1349-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Br — Amneal Pharmaceuticals of New York, LLC
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May 29, 2020 · Class II · Ongoing · D-1345-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Brid — Amneal Pharmaceuticals of New York, LLC
-
May 29, 2020 · Class II · Ongoing · D-1347-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridg — Amneal Pharmaceuticals of New York, LLC
Showing the newest 25 of 30.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Metformin hydrochloride, Oceanside Pharmaceuticals, effective November 14, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →