Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India
Zydus Pharmaceuticals USA recalls 4 mg MethylPREDNISolone tablets due to cross contamination from CGMP cleaning failures. Affected lots expire Feb 2020 or later. No remedy specified in recall notice.
Recall notice
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Contact the company & request your remedy
What happened, in plain English
Zydus Pharmaceuticals is recalling 4 mg MethylPREDNISolone tablets that may have been cross-contaminated during manufacturing. This could pose a risk of unintended medication exposure. The recall affects specific production lots with expiration dates through July 2020. Read more at govinfonow.com/recall/38828-zydus-methylprednisolone-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38828-zydus-methylprednisolone-tablets-recall-cross-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1448-2019
Cite this page
“Zydus MethylPREDNISolone Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38828-zydus-methylprednisolone-tablets-recall-cross-contamination-risk. Based on FDA recall #D-1448-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1448-2019%22&limit=1).
Why it’s dangerous
Cross contamination during manufacturing could introduce other medications into the product. This might lead to unintended medication exposure when taken by patients. The risk is related to the manufacturing process failure, not the product itself.
Who’s affected
Prescription holders of the affected 4 mg MethylPREDNISolone tablets. Patients using these medications for conditions like inflammation or autoimmune disorders are most at risk.
How to tell if you have this one
Check for the product name 'MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets' on the label. Look for lot numbers M800144, M800145 (expiring Feb 2020) or M808193, M811096 (expiring June or July 2020).
- Brand
Zydus Pharmaceuticals- Category
Drug
All 14 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1440-2019 | ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06; Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21. | 1,425,264 30-count bottles | 68382-209-06, 68382-209-10 |
| D-1441-2019 | Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10; Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20 | 768 1000-count bottles | 68382-209-06, 68382-209-10 |
| D-1442-2019 | Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10; Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-20 | 204 1000-count bottles | — |
| D-1443-2019 | Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16; Lot: M714176, M714177, EXP Oct-19; M714917, EXP Nov-19; M714918, M715594, M715595, EXP Dec-19; M802190, EXP Jan-20; M802191, EXP Feb-20, M808673, EXP May-20; M811125, M811126, M811127, M811128, M811129, EXP Jun-20; M815082, M815083, M815084, M815085, M815086 EXP Aug-20; M900476, M900477, M900478, M900479, M900481, Dec-20; | 143,184 90-count bottles | — |
| D-1444-2019 | Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16; Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19; M808307, M808308, M808309, M808310, EXP May-20; M812479, M812481, M812482, M812483, EXP Jul-20; M815787 M815789, M815790, M815791, M815788, EXP Sep-20; M820266, M820267, M820268, M820269, M820265 EXP Nov-20; M903040, M903041, M903042 EXP Jan-21. | 215,760 90-count bottles | — |
| D-1445-2019 | Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10; Lots: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20 | 3,156 1000-count bottles | — |
| D-1446-2019 | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16; Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21 | 168,330 90-count bottles | — |
| D-1447-2019 | Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16; Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20 | 113,304 90-count bottles | — |
| D-1448-2019 | MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01; Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20 | 34521 100-count bottles | 68382-916-01, 68382-916-05, 68382-916-34, 68382-917-11, 68382-917-01, 68382-917-05, 68382-917-30, 68382-917-77, 68382-918-18, 68382-918-01, 68382-918-05, 68382-918-30, 68382-918-77, 68382-919-11, 68382-919-01, 68382-919-05, 68382-919-30, 68382-919-77 |
| D-1449-2019 | MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34; Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21 | N/A | 68382-916-01, 68382-916-05, 68382-916-34, 68382-917-11, 68382-917-01, 68382-917-05, 68382-917-30, 68382-917-77, 68382-918-18, 68382-918-01, 68382-918-05, 68382-918-30, 68382-918-77, 68382-919-11, 68382-919-01, 68382-919-05, 68382-919-30, 68382-919-77 |
| D-1450-2019 | MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18; lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20 | N/A | 68382-916-01, 68382-916-05, 68382-916-34, 68382-917-11, 68382-917-01, 68382-917-05, 68382-917-30, 68382-917-77, 68382-918-18, 68382-918-01, 68382-918-05, 68382-918-30, 68382-918-77, 68382-919-11, 68382-919-01, 68382-919-05, 68382-919-30, 68382-919-77 |
| D-1451-2019 | MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11; Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20. | 13,564 25-count bottles | 68382-916-01, 68382-916-05, 68382-916-34, 68382-917-11, 68382-917-01, 68382-917-05, 68382-917-30, 68382-917-77, 68382-918-18, 68382-918-01, 68382-918-05, 68382-918-30, 68382-918-77, 68382-919-11, 68382-919-01, 68382-919-05, 68382-919-30, 68382-919-77 |
| D-1452-2019 | Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16; Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20 | 47,664 90-count bottles | — |
| D-1453-2019 | MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11; Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21 | 40872 25-count bottles | 68382-916-01, 68382-916-05, 68382-916-34, 68382-917-11, 68382-917-01, 68382-917-05, 68382-917-30, 68382-917-77, 68382-918-18, 68382-918-01, 68382-918-05, 68382-918-30, 68382-918-77, 68382-919-11, 68382-919-01, 68382-919-05, 68382-919-30, 68382-919-77 |
What to do — step by step
Check Product Details
Verify the product name, lot number, and expiration date on the label to determine if it's affected.
Questions people ask
Why is this product being recalled?
The recall is due to cross contamination from CGMP cleaning failures during manufacturing.
What should I do if I have this product?
The recall notice does not specify a remedy, so check the product details to see if it's affected.
Are there any safety risks from this product?
The recall indicates a potential risk of unintended medication exposure due to cross contamination.
Contact Zydus Pharmaceuticals
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1448-2019 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-1448-2019 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1448-2019 (May 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1448-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.