The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1476–1500 of 1563

  • ModerateFDA (Drugs)·D-1266-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

    Wockhardt USA is recalling 539 drums of Famotodine Tablets, 20 mg, because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1243-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1245-2015·2015-07-29

    Wockhardt Recalls Lamotrigine Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, because the firm did not adequately investigate customer complaints.

    Product
    Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1248-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhard
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1247-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1250-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of customer complaints.

    Product
    Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1244-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 2.5 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1272-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1252-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1273-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures

    Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1257-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling specific lots of Lisinopril 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Wat
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1277-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 68,969 bottles of Captopril 100 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1261-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Lisinopril 40 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 W
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1259-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 20 mg, due to inadequate investigation of customer complaints. The recall covers nationwide distribution.

    Product
    Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1263-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1253-2015·2015-07-29

    Wockhardt Recalls Tamsulosin Hydrochloride Capsules Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules because the firm did not adequately investigate customer complaints, a Current Good Manufacturing Practice (CGMP) deviation.

    Product
    Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1264-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1275-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.

    Product
    Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1251-2015·2015-07-29

    Wockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures

    Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1269-2015·2015-07-29

    Wockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling specific lots of Lansoprazole Delayed-Release Capsules because the manufacturer did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Zonisamide Capsules, 25 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1255-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide