Recall archive
16 recalls · page 1 of 1
Reported Dec 23, 2020
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals (USA) Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 11, 2020
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals (USA) Inc.
Matched: Brand · Product details — Failed Dissolution Specification
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 29, 2017
ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Legacy Pharmaceutical Packaging LLC
Matched: Brand · Product details — Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
FDA (openFDA drug enforcement)
Reported Mar 29, 2017
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
FDA (openFDA drug enforcement)
Reported Dec 28, 2016
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Dissolution Specifications; 6 month time point
FDA (openFDA drug enforcement)
Reported Nov 30, 2016
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
FDA (openFDA drug enforcement)
Reported Sep 14, 2016
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term…
FDA (openFDA drug enforcement)
Reported Aug 24, 2016
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Dissolution Specifications: out of specification dissolution results in retained samples
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 2, 2016
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
FDA (openFDA drug enforcement)
Reported Dec 3, 2014
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
FDA (openFDA drug enforcement)
Reported Oct 22, 2014
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
FDA (openFDA drug enforcement)
Reported Oct 15, 2014
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
FDA (openFDA drug enforcement)
Reported May 28, 2014
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
FDA (openFDA drug enforcement)
Reported Aug 14, 2013
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were…
FDA (openFDA drug enforcement)
Reported Apr 3, 2013
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
FDA (openFDA drug enforcement)
Reported Aug 8, 2012
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zydus Pharmaceuticals USA Inc.
Matched: Brand · Product details — Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The…
FDA (openFDA drug enforcement)
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