Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bo...
FDA Drug Recall #D-0011-2023 — Class II — October 6, 2022
Recall Summary
| Recall Number | D-0011-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 6, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Golden State Medical Supply Inc. |
| Location | Camarillo, CA |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
Reason for Recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Distribution Pattern
USA nationwide
Lot / Code Information
Lot#: a) GS041430, GS041941, Exp 1/31/2023; GS041315, GS042991, GS043027, GS043367, GS043501, GS044421, Exp 3/31/2023; b) GS041431, GS041799, GS042287, GS042414, GS042879, Exp: 1/31/2023; GS041316, GS042992, GS043368, GS043579, Exp 3/31/2023; c) GS041429, GS041877, Exp 1/31/2023; GS041317, GS043028, GS043366, GS044422, Exp 3/31/2023
Other Recalls from Golden State Medical Supply Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0235-2026 | Class II | Baclofen Tablets USP, 10 mg, 1000-count bottles... | Nov 26, 2025 |
| D-0158-2026 | Class II | NIACIN Extended-Release Tablets, USP, 1,000 mg,... | Oct 20, 2025 |
| D-0287-2025 | Class II | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx ... | Mar 5, 2025 |
| D-0568-2024 | Class II | Duloxetine Delayed-Release Capsules, USP, 30mg,... | May 13, 2024 |
| D-0349-2024 | Class II | Fluticasone Propionate Nasal Spray USP, 50 mcg ... | Feb 14, 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.