The Recall Desk

Manufacturer

Breckenridge Pharmaceutical, Inc.

35 recalls in our database name Breckenridge Pharmaceutical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
35
Critical
0
Severe
0
Most recent
2026-06-17

Of the 35 recalls from Breckenridge Pharmaceutical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–35 of 35

  • HighFDA (Drugs)·D-0459-2023·2023-03-22

    Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk

    Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.

    Product
    Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0460-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.

    Product
    Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0461-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceuticals is recalling Alprazolam 2 mg tablets nationwide due to manufacturing practice deviations creating potential cross-contamination risk. Affected tablets are distributed in 100-count and 500-count bottles.

    Product
    Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0462-2023·2023-03-22

    Clobazam tablets recalled for potential manufacturing cross-contamination risk

    Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.

    Product
    Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0308-2021·2021-03-24

    Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities

    Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.

    Product
    Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1050-2020·2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the product converting to Solifenacin Tartrate.

    Product
    Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1051-2020·2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.

    Product
    Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pith
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1063-2020·2020-03-04

    Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

    Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

    Product
    Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0279-2019·2018-11-21

    Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures

    Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.

    Product
    Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
    Category
    Drug
    Distribution
    Distributed nationwide