Wockhardt Usa Inc.: 45 FDA recall reports
Every drug recall the FDA has published for Wockhardt Usa Inc.. The fault, and how the agency graded it.
45Reports
0Class I
0Ongoing
2017-11-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M
D-0051-2018 · Class III · reported 2017-11-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
- Product
- Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
- Where it went
- Nationwide in the USA
- How much
- 5050 bottles
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India;
D-1346-2015 · Class II · reported 2015-08-26 · Terminated
- Why it was recalled
- CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
- Product
- Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
- Where it went
- Nationwide
- How much
- 1704 bottles
Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India;
D-1347-2015 · Class II · reported 2015-08-26 · Terminated
- Why it was recalled
- CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
- Product
- Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
- Where it went
- Nationwide
- How much
- 3378 bottles
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bot
D-1265-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. M
D-1266-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 539 Drums
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mu
D-1249-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 59,729 Bottles
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bot
D-1250-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate 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 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 6467
D-1271-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons.
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 50
D-1262-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 36,213 Bottles and B) 12,824 Bottles.
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bott
D-1261-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles.
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000
D-1256-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 152,164 Bottles and B) 50,991 Bottles.
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bot
D-1259-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- 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 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles.
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt
D-1243-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 124,034 Bottles
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 T
D-1263-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 112,120 Bottles and B) 178,580 Cartons.
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01)
D-1246-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 53,894 Bottles
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02)
D-1253-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- 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, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 407,958 Bottles
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Lim
D-1245-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 5,910 Bottles
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Coun
D-1248-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count
D-1244-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 149,924 Bottles and B) 35,012 Bottles
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 6467
D-1272-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons.
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 646
D-1252-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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. Parsippany, NJ 07054 USA .
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 33,422 Bottles and B) 940 Bottles.
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count
D-1275-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 162,743 Bottles and B) 14,205 Bottles
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limit
D-1273-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 84,542 Bottles
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouch
D-1251-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 848 Pouches
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt L
D-1264-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 7,584 Bottles
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottle
D-1257-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufacture
D-1268-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Product
- Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, 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: 64679-0669-01.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 16,276 Bottles
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockh
D-1247-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 37,791 Bottles
Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Lim
D-1277-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: 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.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- 68,969 Bottles
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-0
D-1269-2015 · Class II · reported 2015-07-29 · Terminated
- Why it was recalled
- CGMP Deviations: Firm 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: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
- Where it went
- U.S. Nationwide including Puerto Rico.
- How much
- A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
Showing the 30 most recent of 45. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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