Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500...
FDA Drug Recall #D-0459-2023 — Class II — March 2, 2023
Recall Summary
| Recall Number | D-0459-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 2, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Breckenridge Pharmaceutical, Inc |
| Location | Berlin, CT |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Reason for Recall
CGMP Deviations: Potential risk of Cross Contamination
Distribution Pattern
USA nationwide.
Lot / Code Information
Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date 2/28/2025; 5220559, exp. date 5/31/2025; b) 5210650, exp. date 3/31/2023, 5210651, exp. date 3/31/2023 5210652, exp. date 3/31/2023 5210653, exp. date 3/31/2023 5210674, exp. date 3/31/2023 5210732, exp. date 3/31/2023 5210733, exp. date 4/30/2023 5210753, exp. date 4/30/2023 5210902, exp. date 5/31/2023 5210903, exp. date 5/31/2023 5210904, exp. date 5/31/2023 5211231, exp. date 7/31/2023 5211281, exp. date 7/31/2024 5211282, exp. date 7/31/2024 5211283, exp. date 7/31/2024 5211284, exp. date 7/31/2024 5211336, exp. date 7/31/2024 5211337, exp. date 8/31/2024 5211338, exp. date 8/31/2024 5211462, exp. date 9/30/2024 5211463, exp. date 9/30/2024 5211464, exp. date 9/30/2024 5211465, exp. date 9/30/2024 5211516, exp. date 9/30/2024 5211644, exp. date 10/31/2024 5211645, exp. date 10/31/2024 5211690, exp. date 10/31/2024 c) 5210675, exp. date 3/31/2023 5210777, exp. date 4/30/2023 5210778, exp. date 4/30/2023 5210996, exp. date 5/31/2023 5211077, exp. date 6/30/2023 5211078, exp. date 6/30/2023 5211079, exp. date 6/30/2023 5211080, exp. date 6/30/2023 5211364, exp. date 8/31/2024 5211365, exp. date 8/31/2024 5211367, exp. date 8/31/2024 5211366, exp. date 8/31/2024 5211575, exp. date 10/31/2024 5211576, exp. date 10/31/2024 5211694, exp. date 11/30/2024 5220066, exp. date 12/31/2024
Other Recalls from Breckenridge Pharmaceutical, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0387-2025 | Class II | Duloxetine Delayed-Release Capsules USP, 60 mg,... | Apr 14, 2025 |
| D-0388-2025 | Class II | Duloxetine Delayed-Release Capsules USP, 30 mg,... | Apr 14, 2025 |
| D-0161-2025 | Class II | Duloxetine Delayed-Release Capsules, USP, 30mg,... | Dec 6, 2024 |
| D-0162-2025 | Class II | Duloxetine Delayed-Release Capsules, USP, 60 mg... | Dec 6, 2024 |
| D-0009-2025 | Class II | Duloxetine Delayed-Release Capsules, USP, 20mg,... | Oct 10, 2024 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
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.