RecallRadar

FDA Drug recall D-1062-2016

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant…

On 2016-07-13 the FDA classified a Class III recall of Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant… by Lyne Laboratories, citing subpotency: product assayed and found OOS for cyproheptadine.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1062-2016
ClassificationClass III
Statusterminated
Initiated2016-06-07
Published2016-07-13
Last updated2026-09-13 11:51 UTC
CompanyLyne Laboratories
DistributionNJ

Product

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48

Reason

Subpotency: product assayed and found OOS for cyproheptadine

Identifiers

code_infoLot #: CR1603, Exp 12/17

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-1062-2016%22

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