Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15)
Medicine recall D-1305-2020. Published in FDA’s Enforcement Report on Jun 24, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 24, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,586,913 bottles how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
1,586,913 bottles, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: a) 23537 Exp. 06/30/2020, 23613 Exp. 06/30/2020, 24083 Exp. 06/30/2020, 24291 Exp. 06/30/2020, 24725 Exp. 06/30/2020, 25637 Exp. 06/30/2021, 25751 Exp. 07/31/2021; b) 22073 Exp. 06/30/2020, 22460 Exp. 07/31/2020, 22539 Exp.…
Every code shown here, 1,999 characters
Lots: a) 23537 Exp. 06/30/2020, 23613 Exp. 06/30/2020, 24083 Exp. 06/30/2020, 24291 Exp. 06/30/2020, 24725 Exp. 06/30/2020, 25637 Exp. 06/30/2021, 25751 Exp. 07/31/2021; b) 22073 Exp. 06/30/2020, 22460 Exp. 07/31/2020, 22539 Exp. 09/30/2020, 22540 Exp. 09/30/2020, 23299 Exp. 01/31/2021, 23300 Exp. 01/31/2021, 23484 Exp. 01/31/2021, 23917 Exp. 03/31/2021, 24477 Exp. 06/30/2021, 24514 Exp. 06/30/2021, 24945 Exp. 08/31/2021, 25591 Exp. 10/31/2021, 25590 Exp. 10/31/2021, 26004 Exp. 11/30/2021, 26322 Exp. 01/31/2021, 26339 Exp. 02/28/2022, 26520 Exp. 01/31/2022, 26588 Exp. 02/28/2022; c) 22202 Exp. 06/30/2020, 22541 Exp. 09/30/2020, 23293 Exp. 01/31/2021, 23475 Exp. 01/31/2021, 23658 Exp. 03/31/2021, 23979 Exp. 03/31/2021, 24303 Exp. 06/30/2021, 24476 Exp. 06/30/2021, 24550 Exp. 06/30/2021, 24804 Exp. 07/31/2021, 25380 Exp. 08/31/2021, 25592 Exp. 10/31/2021, 25736 Exp. 10/31/2021, 26005 Exp. 11/30/2021, 26006 Exp. 10/31/2021, 26326 Exp. 01/31/2022, 26483 Exp. 02/28/2022, 26484 Exp. 02/28/2022,26589 Exp. 02/28/2022; d) 22430 Exp. 06/30/2020, 22538 Exp. 09/30/2020, 22638 Exp. 09/30/2020, 22639 Exp. 09/30/2020, 23292 Exp. 01/31/2021, 23291 Exp. 01/31/2021, 23344 Exp. 01/31/2021, 23631 Exp. 01/31/2021, 23707 Exp. 03/31/2021, 23706 Exp. 03/31/2021, 24164 Exp. 05/31/2021, 24165 Exp. 05/31/2021, 24340 Exp. 06/30/2021, 24474 Exp. 06/30/2021, 24475 Exp. 06/30/2021, 24548 Exp. 06/30/2021, 24738 Exp. 07/31/2021, 24739 Exp. 07/31/2021, 24905 Exp. 07/31/2021, 24906 Exp. 08/31/2021, 25379 Exp. 08/31/2021, 25378 Exp. 08/31/2021, 25627 Exp. 10/31/2021, 25664 Exp. 10/31/2021, 26131 Exp. 01/31/2022, 26340 Exp. 01/31/2022, 26341 Exp. 02/28/2022, 26590 Exp. 02/28/2022, 26591 Exp. 02/28/2022; e) HH01618A Exp. 07/31/2020, HH01718A Exp. 07/31/2020, HH01818A Exp. 07/31/2020, HH01918A Exp. 07/31/2020, HH02018A Exp. 08/31/2020, HH05018A Exp. 08/31/2020, HH05118A Exp. 08/31/2020, HH05218A Exp. 08/31/2020, HH05318A Exp. 08/31/2020, HH05418A Exp. 08/31/2020, HH05518A Exp. 08/31/2020, HH05618A Exp.…
FDA’s list runs to 4,583 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
50268-531-15 -
NDC
42291-610-90 -
NDC
42291-610-18 -
NDC
42291-610-36 -
NDC
42291-610-10
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 4, 2020.
- FDA classified it on Jun 12, 2020.
- FDA’s Enforcement Report published it on Jun 24, 2020.
- FDA terminated it on Jan 14, 2022.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- AVKARE Inc., of Pulaski, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,583 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.