RecallRadar

FDA Drug recall D-848-2013

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

On 2013-08-14 the FDA classified a Class II recall of Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 by Teva Pharmaceuticals Usa, citing failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-848-2013
ClassificationClass II
Statusterminated
Initiated2013-06-18
Published2013-08-14
Last updated2026-09-13 11:51 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

Reason

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Identifiers

ndc0093-5346-01
ndc0093-5347-01
ndc0093-5348-01
code_info34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-848-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.