The Recall Desk

Manufacturer

Caraco Pharmaceutical Laboratories, Ltd.

12 recalls in our database name Caraco Pharmaceutical Laboratories, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
3
Most recent
2014-08-13

Of the 12 recalls from Caraco Pharmaceutical Laboratories, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (25%) 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.

1–12 of 12

  • ModerateFDA (Drugs)·D-1511-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations

    Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1510-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1415-2014·2014-07-09

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Caraco Pharmaceutical Laboratories is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highwa
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2014·2014-07-02

    Caraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns

    Caraco Pharmaceutical Laboratories is recalling 200 vials of Gemcitabine For Injection USP due to a lack of assurance of sterility.

    Product
    Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1297-2014·2014-05-07

    Caraco Recalls Children's Cetirizine Tablets Due to Impurity Failures

    Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1284-2014·2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failure

    Caraco Pharmaceutical Laboratories is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah Mc
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1283-2014·2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Caraco Pharmaceutical Laboratories is recalling 160,105 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McC
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1296-2014·2014-05-07

    Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities

    Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.

    Product
    Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2014·2014-03-05

    Caraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence

    Caraco Pharmaceutical is recalling 2,528 bottles of Metformin HCl ER 500 mg tablets because a customer reported finding Gabapentin tablets in the bottle.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1081-2014·2014-02-19

    Caraco Recalls Oxcarbazepine Tablets Due to Broken Tablets

    Caraco Pharmaceutical Laboratories is recalling 7,005 bottles of Oxcarbazepine 300 mg tablets because some tablets are broken.

    Product
    OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-089-2013·2012-12-12

    Caraco Recalls Tramadol Tablets Due to Foreign Metoprolol Contamination

    Caraco is recalling Tramadol HCl 50 mg tablets because a customer reported finding Metoprolol Tartrate tablets in a bottle.

    Product
    traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-003-2013·2012-10-10

    Caraco Recalls Nimodipine Capsules Due to Crystallization

    Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories,
    Category
    Drug
    Distribution
    1 state