Metformin HCl Extended Release Tablets — Class II drug recall D-1364-2020
Terminated recall by Preferred Pharmaceuticals, Inc., reported 2020-07-08, distributed in FL. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily
| Recall number | D-1364-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc., Anaheim, CA, United States |
| Recall initiated | 2020-06-17 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2024-03-21 |
| Distributed | FL |
| Quantity | 144 bottles |
| Reason classes | chemical contamination, cgmp |
| NDC | 68788-6932-01 |
| Expiration dates | 2020-12 |
Product
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1364-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.