PillMetformin Hydrochloride
Metformin Hydrochloride
38 active makers
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US acquisition costNADAC · per unit
Average across 52 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it38 active · 1 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Bryant Ranch Prepack | repackager | 70 | SUPPLYING |
| Aphena Pharma Solutions - Tennessee, LLC | unknown | 63 | SUPPLYING |
| PD-Rx Pharmaceuticals, Inc. | unknown | 31 | SUPPLYING |
| A-S Medication Solutions | unknown | 28 | SUPPLYING |
| Preferred Pharmaceuticals Inc. | unknown | 21 | SUPPLYING |
| Proficient Rx LP | unknown | 21 | SUPPLYING |
| Amneal Pharmaceuticals LLC | unknown | 19 | SUPPLYING |
| Laurus Labs Limited | unknown | 14 | SUPPLYING |
| Ascend Laboratories, LLC | unknown | 13 | SUPPLYING |
| Northwind Health Company, LLC | unknown | 12 | SUPPLYING |
| Unichem Pharmaceuticals (USA), Inc. | unknown | 11 | SUPPLYING |
| AvKARE | unknown | 10 | SUPPLYING |
| NuCare Pharmaceuticals, Inc. | unknown | 10 | SUPPLYING |
| MARKSANS PHARMA LIMITED | unknown | 9 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 9 | SUPPLYING |
+ 24 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Feb 25, 2025RECALLRecall (Class II): METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 6…
Presence of Foreign Tablets/Capsules. — Recalling firm: A-S Medication Solutions LLC — Nationwide in U.S.
- Dec 27, 2021RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. — Recalling firm: VIONA PHARMACEUTICALS INC — Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Jun 1, 2021RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare …
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. — Recalling firm: VIONA PHARMACEUTICALS INC — Nationwide in the US
- May 4, 2021RECALLRecall (Class II): Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharma…
Presence of foreign substance: identified as activated carbon. — Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC — USA Nationwide
- Mar 25, 2021RECALLRecall (Class III): Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceut…
Failed Moisture Limits: Out of specification for water content — Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC — Nationwide in the USA
- Oct 12, 2020RECALLRecall (Class II): Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) — Recalling firm: Direct Rx — FL
- Oct 6, 2020RECALLRecall (Class II): 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…
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) — Recalling firm: PD-Rx Pharmaceuticals, Inc. — AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Oct 6, 2020RECALLRecall (Class II): metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 4…
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) — Recalling firm: PD-Rx Pharmaceuticals, Inc. — AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Oct 2, 2020RECALLRecall (Class II): Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100…
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Marksans Pharma Limited — Nationwide
- Oct 2, 2020RECALLRecall (Class II): Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufacture…
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Marksans Pharma Limited — Nationwide
- Aug 19, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceutic…
CGMP Deviations — Recalling firm: BAYSHORE PHARMACEUTICALS — nationwide
- Aug 19, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceutica…
CGMP Deviations — Recalling firm: BAYSHORE PHARMACEUTICALS — nationwide
- Jul 7, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharma…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed throughout the United States.
- Jul 7, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharma…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed throughout the United States.
- Jul 7, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharma…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed throughout the United States.
- Jul 7, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmac…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed throughout the United States.
- Jun 11, 2020RECALLRecall (Class II): Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmace…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed throughout the United States.
- Jun 5, 2020RECALLRecall (Class II): metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-0…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: PD-Rx Pharmaceuticals, Inc. — United States.
- Jun 5, 2020RECALLRecall (Class II): Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactu…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Marksans Pharma Limited — Nationwide
- May 29, 2020RECALLRecall (Class II): amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Amneal Pharmaceuticals of New York, LLC — Nationwide
- May 29, 2020RECALLRecall (Class II): amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amn…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Amneal Pharmaceuticals of New York, LLC — Nationwide
- May 29, 2020RECALLRecall (Class II): amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amn…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Amneal Pharmaceuticals of New York, LLC — Nationwide
- May 29, 2020RECALLRecall (Class II): amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Am…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Recalling firm: Amneal Pharmaceuticals of New York, LLC — Nationwide
- Jul 3, 2018RECALLRecall (Class II): Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by:…
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet. — Recalling firm: Sun Pharmaceutical Industries, Inc. — AZ
- Jan 28, 2014RECALLRecall (Class II): Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical I…
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER — Recalling firm: Caraco Pharmaceutical Laboratories, Ltd. — Nationwide