CLASS II ONGOING Drug recall · Reported 14 Apr 2021 · FDA Enforcement Report
Guanfacine Extended-Release Tablets 2 mg recalled by Apotex
Apotex is recalling Guanfacine Extended-Release Tablets 2 mg, distributed nationwide in the US. The recall was initiated on 31 Mar 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0324-2021
- FDA event ID
- 87648
- Recalling firm
- Apotex, Weston, FL
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2021
- FDA classified
- 6 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 31 Mar 2021 | Recall initiated by company | |
| 6 Apr 2021 | Classified by FDA | +6 days |
| 14 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Which lots are affected?
Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apotex
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|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
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| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
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Other Guanfacine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | guanFACINE HCl, Tablet, 1 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | guanFACINE HCl Tablet, 2 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |