Zydus Recalls Methylprednisolone Tablets Due to Contamination Risk
Zydus Pharmaceuticals recalls specific lots of 4 mg Methylprednisolone tablets due to CGMP deviations and potential cross-contamination.
Use caution until it’s fixed
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Contact the company
What happened, in plain English
Zydus Pharmaceuticals USA Inc is recalling Methylprednisolone Tablets, USP, 4 mg because of current Good Manufacturing Practice (CGMP) deviations. The issue stems from a cleaning failure that could lead to cross-contamination with other products. This recall affects approximately 34,521 bottles distributed nationwide in the USA. Read more at govinfonow.com/recall/38828-zydus-recalls-methylprednisolone-tablets-due-to-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38828-zydus-recalls-methylprednisolone-tablets-due-to-contamination-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1448-2019
Cite this page
“Zydus Recalls Methylprednisolone Tablets Due to Contamination Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38828-zydus-recalls-methylprednisolone-tablets-due-to-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
The hazard arises from a failure in cleaning procedures during manufacturing, which can cause cross-contamination with other products. This means the tablets may contain unintended substances, potentially affecting their safety and efficacy for the patient.
Who’s affected
Patients who have been prescribed or possess Methylprednisolone Tablets, USP, 4 mg from Zydus Pharmaceuticals, specifically those with lots manufactured by Cadila Healthcare Ltd. Individuals using these tablets for medical treatment are the primary group affected.
How to tell if you have this one
Check your medication bottle for the National Drug Code (NDC) 68382-916-01. Verify the lot numbers: M800144 (Exp Feb-20), M800145 (Exp Feb-20), M808193 (Exp Jun-20), or M811096 (Exp Jul-20). The product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India.
- 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 your medication
Verify if your bottle matches the NDC 68382-916-01 and one of the recalled lot numbers (M800144, M800145, M808193, or M811096).
Contact your pharmacist
If you have the recalled product, speak with your pharmacist or healthcare provider immediately to discuss next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-a3b on October 11, 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.