Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202...
FDA Drug Recall #D-0098-2023 — Class II — December 20, 2022
Recall Summary
| Recall Number | D-0098-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 20, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RemedyRepack Inc. |
| Location | Indiana, PA |
| Product Type | Drugs |
| Quantity | 132 Cards of 30 = 3960 Tablets |
Product Description
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Reason for Recall
Failed Impurities/Degradation specifications
Distribution Pattern
Product was distributed to one account in PA.
Lot / Code Information
Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
Other Recalls from RemedyRepack Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0411-2025 | Class II | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsul... | Apr 22, 2025 |
| D-0378-2025 | Class II | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsul... | Mar 24, 2025 |
| D-0217-2025 | Class II | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Bl... | Jan 24, 2025 |
| D-0165-2025 | Class II | Duloxetine Delayed-Release Capsules, 60 mg, a) ... | Dec 2, 2024 |
| D-0611-2024 | Class II | Potassium Chloride Micro 10mEq K (750 mg) Exten... | Jun 26, 2024 |
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.