Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, ...
FDA Drug Recall #D-0284-2024 — Class II — January 5, 2024
Recall Summary
| Recall Number | D-0284-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 5, 2024 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lupin Pharmaceuticals Inc. |
| Location | Baltimore, MD |
| Product Type | Drugs |
| Quantity | 165,60 bottles |
Product Description
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Reason for Recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Distribution Pattern
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Lot / Code Information
A200817 exp 1/2024
Other Recalls from Lupin Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0541-2026 | Class II | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx... | Apr 24, 2026 |
| D-0220-2026 | Class II | Ganirelix Acetate Injection, 250 mcg/0.5mL, Sin... | Nov 13, 2025 |
| D-0227-2026 | Class II | Sertraline Hydrochloride Tablets USP, 100 mg, 9... | Nov 5, 2025 |
| D-0542-2025 | Class II | Amlodipine and Benazepril HCl Capsules USP 2.5 ... | Jul 2, 2025 |
| D-0537-2025 | Class II | clomiPRAMINE Hydrochloride Capsules USP 25 mg, ... | Jun 27, 2025 |
Frequently Asked Questions
Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.
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.