Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 ...
FDA Drug Recall #D-0394-2023 — Class II — February 7, 2023
Recall Summary
| Recall Number | D-0394-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 7, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accord Healthcare, Inc. |
| Location | Durham, NC |
| Product Type | Drugs |
| Quantity | 992,622 bottles |
Product Description
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution Pattern
United States including Puerto Rico and Canada
Lot / Code Information
Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date 3/31/2024, P2102047 Exp. Date 3/31/2024, P2102049 Exp. Date 3/31/2024, P2102050 Exp. Date 3/31/2024, P2102051 Exp. Date 3/31/2024, P2102052 Exp. Date 3/31/2024, P2103017 Exp. Date 4/30/2024, P2103018 Exp. Date 4/30/2024, P2103900 Exp. Date 6/30/2024, P2104436 Exp. Date 6/30/2024, P2105399 Exp. Date 7/31/2024, P2105400 Exp. Date 7/31/2024, P2106257 Exp. Date 9/30/2024, P2106258 Exp. Date 9/30/2024, P2106259 Exp. Date 9/30/2024, R2101443 Exp. Date 9/30/2024, R2101445 Exp. Date 9/30/2024, R2101444 Exp. Date 9/30/2024, R2200082 Exp. Date 12/31/2024, R2200080 Exp. Date 12/31/2024, R2200079 Exp. Date 12/31/2024, R2200081 Exp. Date 12/31/2024, P2200691 Exp. Date 1/31/2025, P2200692 Exp. Date 1/31/2025, P2200693 Exp. Date 1/31/2025, P2201499 Exp. Date 2/28/2025, P2201498 Exp. Date 2/28/2025, R2200579 Exp. Date 4/30/2025, P2203881 Exp. Date 5/31/2025, P2203441 Exp. Date 5/31/2025, P2203442 Exp. Date 5/31/2025, R2200949 Exp. Date 6/30/2025, R2201094 Exp. Date 6/30/2025, R2201003 Exp. Date 7/31/2025,
Other Recalls from Accord Healthcare, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0006-2026 | Class II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.08... | Sep 16, 2025 |
| D-0521-2025 | Class II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1... | Jun 20, 2025 |
| D-0522-2025 | Class II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.1... | Jun 20, 2025 |
| D-0518-2025 | Class II | Levothyroxine Sodium Tablets, USP, 25 mcg (0.02... | Jun 20, 2025 |
| D-0523-2025 | Class II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.1... | Jun 20, 2025 |
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.