Class III · Low risk
Trokendi XR
Failed dissolution specifications.
Topiramate Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Affected NDC
29300-0116-05
Compare with the code on your package — it is the most precise check available.
Drug: Topiramate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| topiramate NDC 29300-0116 |
50 mg/1 | Tablet, Film Coated Oral |
Unichem Pharmaceuticals (USA), Inc. | Rx |
- Recalling firm
- Unichem Pharmaceuticals USA INC
- NDC code
- 29300-116-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0255-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Topiramate recalls
See all
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class III · Low risk
Eprontia (topiramate)
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II · Moderate risk
Trokendi XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Topiramate 25mg Tabs White/round tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Other recalls by Unichem Pharmaceuticals USA INC
All 2021 recalls
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class II · Moderate risk
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I · High risk
Cyclobenzaprine Hydrochloride Tablets
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
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