Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-...
FDA Drug Recall #D-0460-2023 — Class II — March 2, 2023
Recall Summary
| Recall Number | D-0460-2023 |
| 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, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), 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 # 5210645, exp. date 3/31/2023, 500's Bottle 5210646, exp. date 3/31/2023, 500's Bottle 5210647, exp. date 3/31/2023, 500's Bottle 5210648, exp. date 3/31/2023, 1000's Bottle 5210649, exp. date 3/31/2023, 1000's Bottle 5210831, exp. date 4/30/2023, 100's Bottle 5210832, exp. date 4/30/2023, 500's Bottle 5210833, exp. date 4/30/2023, 500's Bottle 5210834, exp. date 4/30/2023, 1000's Bottle 5210835, exp. date 4/30/2023, 1000's Bottle 5210905, exp. date 5/31/2023, 100's Bottle 5210906, exp. date 5/31/2023, 100's Bottle 5210907, exp. date 5/31/2023, 500's Bottle 5210908, exp. date 5/31/2023, 500's Bottle 5210909, exp. date 5/31/2023, 500's Bottle 5210965, exp. date 5/31/2023, 500's Bottle 5210997, exp. date 5/31/2023, 1000's Bottle 5210998, exp. date 5/31/2023, 1000's Bottle 5211175, exp. date 6/30/2023, 1000's Bottle 5211176, exp. date 6/30/2023, 500's Bottle 5211177, exp. date 6/30/2023, 500's Bottle 5211178, exp. date 6/30/2023, 500's Bottle 5211179, exp. date 6/30/2023, 500's Bottle 5211180, exp. date 6/30/2023, 500's Bottle 5211181, exp. date 6/30/2023, 500's Bottle 5211205, exp. date 7/31/2023, 500 s Bottle 5211206, exp. date 7/31/2023, 500's Bottle 5211227, exp. date 7/31/2023, 1000's Bottle 5211228, exp. date 7/31/2023, 100's Bottle 5211229, exp. date 7/31/2023, 1000's Bottle 5211334, exp. date 8/31/2024, 500's Bottle 5211335, exp. date 8/31/2024, 1000's Bottle 5211456, exp. date 8/31/2024 , 500's Bottle 5211457, exp. date 8/31/2024 , 500's Bottle 5211458, exp. date 8/31/2024, 500's Bottle 5211459, exp. date 9/30/2024, 1000's Bottle 5211727, exp. date 11/30/2024, 100's Bottle 5211730, exp. date 11/30/2024, 1000's Bottle 5220028, exp. date 12/31/2024, 1000's Bottle 5220029, exp. date 12/31/2024, 1000's Bottle 5220288, exp. date 2/28/2025, 100's Bottle
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.