Preferred Pharmaceuticals Inc — Class II drug recall D-0385-2021
Ongoing recall by Preferred Pharmaceuticals, Inc., reported 2021-05-26, distributed in FL. CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (A
| Recall number | D-0385-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc., Anaheim, CA, United States |
| Recall initiated | 2021-04-28 |
| Classified | 2021-05-16 |
| Reported by FDA | 2021-05-26 |
| Distributed | FL |
| Reason classes | chemical contamination, specification failure |
| NDC | 68788-6932-01 |
| Lot numbers | C2520W, E0620F, G2020M, G2720A |
| Expiration dates | 2021-12-31, 2022-04-30 |
Product
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Reason for recall
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
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-0385-2021. 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.