Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Varenicline Tablets (Varenicline Tartrate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Affected NDC
43598-0908-56
Compare with the code on your package — it is the most precise check available.
Drug: Varenicline
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 |
|---|---|---|---|---|
| varenicline tartrate NDC 43598-0908 |
1 mg/1 | Tablet, Film Coated Oral |
Dr. Reddys Laboratories Inc. | Rx |
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 43598-908-56
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0219-2026 · 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.
Other Varenicline recalls
See all
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2025 recalls
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class III · Low risk
Javygtor (sapropterin dihydrochloride)
Failed Impurities/Degradation Specifications
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