Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceutic...
FDA Drug Recall #D-0642-2020 — Class II — December 17, 2019
Recall Summary
| Recall Number | D-0642-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Glenmark Pharmaceuticals Inc., USA |
| Location | Mahwah, NJ |
| Product Type | Drugs |
| Quantity | 1,309,536 bottles |
Product Description
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Natiowide
Lot / Code Information
7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A 7701269A 7701270A 7701278A 7701279A 7701386A 7701400A 7701401A 7701406A 7701421A 7701434A 7701435A 7701436A 7701452A 7701453A 7701521A 7701522B 7701553A 7701554A 7701555A 7701556A 7701582A 7701817A 7701828A 7701829A 7702001A 7702002A 7702003A 7702012A 7702026A 7702027A 7702064A 7702140A 7702253A 7702254A 7702285A 7702286A 7702287A 7702288A 7702294A 7702413A 7702462A 7702491A 7702492A 7702504A 7702505A 7702515A 7702698A 7702699A 7702700A 7702714A 7702719A 7702720A 7702747A 7702748A 7702749A 7702750A 7702751A 7702872A 7702873A 7702874A 7702917A 7702918A 7702919A 7702921A 7702922A 7702923A 7702945A 7703205A 7703410A 7703411A 7703412A 7703413A 7703414A 7703415A 7703451A 7703452A 7703453A 7703578A 7703579A 7703580A 7703581A 7703591A 7703592A 7703593A 7704372A 7704373A 7704374A 7704426A 7704427A 7704432A 7704463A 7704464A 7704465A 7704466A 7704508A 7704509A 7704510A 7704511A 7704512A 7704513A 7704563A 7704564A 7704746A 7704747A 7704748A 7704813A 7704841A 7704989A 7704990A 7705106A 7705320A 7705321A 7705322A 7705323A 7705324A 7705325A 7705326A 7705694A 7705703A 7705704A 7705702A 19190456 19190472 19190490 7701809A 7704862A 7704863A 7704864A 7704865A 7704866A 7704933A 7704934A
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|---|---|---|---|
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| D-0199-2026 | Class III | Bisoprolol Fumarate and Hydrochlorothiazide Tab... | Nov 21, 2025 |
| D-0222-2026 | Class III | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, ... | Nov 18, 2025 |
| D-0662-2025 | Class II | Azelaic Acid Gel, 15%, 50 grams, For Topical Us... | Sep 17, 2025 |
| D-0021-2026 | Class II | Viorele, Desogestrel and Ethinyl Estradiol, USP... | Sep 3, 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.