Drugs & medicalClass III

Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Read the official notice →
Date
2025-12-17
Country
United States
Brand
Dr. Reddy's Laboratories
Product
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…
Classification
Class III
Units
Distributed Nationwide
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Dr. Reddy's Laboratories recalls

  1. 2025-10-15
  2. US
    Drugs & medicalClass II

    Dr. Reddy's Laboratories, Inc. recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or…

    Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

    FDA · DrugDr. Reddy's Laboratories, Inc.Nationwide within the USA.Official notice →
  3. 2025-07-23
  4. US
    Drugs & medicalClass II

    Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited,…

    Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

    FDA · DrugDr. Reddy's Laboratories, Inc.USA NationwideOfficial notice →
  5. 2025-04-23
  6. US
    Drugs & medicalClass I

    Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma…

    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…

    FDA · DrugDr. Reddy's Laboratories, Inc.Nationwide in the USAOfficial notice →
  7. 2024-12-18
  8. US
    Drugs & medicalClass III

    Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…

    Failed Impurities/Degradation Specifications

    FDA · DrugDr. Reddy's Laboratories, Inc.U.S. NationwideOfficial notice →
  9. 2024-11-27
  10. US
  11. 2024-11-13
  12. US
    Drugs & medicalClass II

    Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC…

    Failed Impurities/Degradation Specification

    FDA · DrugDr. Reddy's Laboratories, Inc.Nationwide in the USAOfficial notice →
All 35 Dr. Reddy's Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-17
  2. US
  3. US
  4. US
    Drugs & medicalClass II

    Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for:…

    Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

    FDA · DrugLupin Pharmaceuticals Inc.FL, MA, MI & OHOfficial notice →
  5. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals,…

    Failed stability specifications: Out of specification for hardness test

    FDA · DrugCipla USA, Inc.Nationwide in the USAOfficial notice →
  6. 2025-12-11
  7. US
    Drugs & medical

    Uuoeebb Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violate Mandatory Standard for Infant Walkers; Sold on Amazon…

    The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant…

    CPSCAbout 2,650Official notice →
  8. 2025-12-10
  9. US
    Drugs & medicalClass II

    Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD,…

    An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell…

    FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT,…Official notice →
See all drugs & medical recalls →