FDA Drug recall D-0385-2021
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab
- FDA Drug
- Class II
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab by Preferred Pharmaceuticals, citing CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0385-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-28 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | FL |
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
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Identifiers
| code_info | Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Preferred Pharmaceuticals
- Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 6…
FDA Drug · Class II · 2026-10-14 · Preferred Pharmaceuticals - Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care
FDA Drug · Class II · 2026-04-15 · Preferred Pharmaceuticals - Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals ND…
FDA Drug · Class II · 2025-12-24 · Preferred Pharmaceuticals - Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03
FDA Drug · Class II · 2025-05-07 · Preferred Pharmaceuticals - Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, ND…
FDA Drug · Class II · 2024-09-04 · Preferred Pharmaceuticals
All Preferred Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.