Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc....

FDA Drug Recall #D-0324-2021 — Class II — March 31, 2021

Recall Summary

Recall Number D-0324-2021
Classification Class II — Moderate risk
Date Initiated March 31, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Apotex Corp.
Location Weston, FL
Product Type Drugs
Quantity 55620 bottles

Product Description

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

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot #: RX1662, RX1663, RX1664 Exp. 11/2022

Other Recalls from Apotex Corp.

Recall # Classification Product Date
D-0407-2026 Class II Brimonidine Tartrate/Timolol Maleate Ophthalmic... Mar 5, 2026
D-0676-2025 Class II Brimonidine Tartrate/Timolol Maleate Ophthalmic... Sep 5, 2025
D-0677-2025 Class II Ketorolac Tromethamine Ophthalmic Solution, 0.5... Sep 5, 2025
D-0457-2025 Class II Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL... May 28, 2025
D-0494-2025 Class II Ketorolac Tromethamine Ophthalmic Solution, 0.5... May 28, 2025

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.