Guanfacine Extended-Release Tablets 2 mg — Class II drug recall D-0324-2021
Ongoing recall by Apotex Corp., reported 2021-04-14, distributed nationwide. Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
| Recall number | D-0324-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2021-03-31 |
| Classified | 2021-04-06 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 55,620 bottles |
| UPC / GTIN / UDI-DI | 00360505392810 |
| NDC | 60505-3927, 60505-3927-01, 60505-3927-03, 60505-3927-08, 60505-3928, 60505-3928-01, 60505-3928-03, 60505-3928-08, 60505-3929, 60505-3929-01, 60505-3929-03, 60505-3929-08, 60505-3930, 60505-3930-01, 60505-3930-03, 60505-3930-08 |
| Lot numbers | RX1662, RX1663, RX1664 |
| Expiration dates | 2022-11 |
Product
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0
Reason for recall
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
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-0324-2021. 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.