Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distri...
FDA Drug Recall #D-0031-2026 - Class II, October 10, 2025
Recall Summary
| Recall Number | D-0031-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | October 10, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Harvard Drug Group LLC |
| Location | Dublin, OH |
| Product Type | Drugs |
Product Description
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Distribution Pattern
US Nationwide.
Lot / Code Information
Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
Other Recalls from The Harvard Drug Group LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0609-2026 | Class II | Carton Label: MAJOR, Methylergonovine Maleate T... | Jun 16, 2026 |
| D-0493-2026 | Class II | Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gr... | Apr 9, 2026 |
| D-0485-2026 | Class II | Memantine Hydrochloride Extended-Release, Capsu... | Mar 24, 2026 |
| D-0383-2026 | Class II | Midodrine Hydrochloride Tablets, USP, 5 mg, 50 ... | Feb 17, 2026 |
| D-0030-2026 | Class II | Gabapentin Capsules, USP, 100 mg, 100 Capsules ... | Oct 10, 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.