CLASS III Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg recalled

Lyne Laboratories is recalling Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg, distributed in New Jersey. The recall was initiated on 7 Jun 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: CR1603, Exp 12/17

Quantity recalled12,215 Bottles shipped to Rising Pharmaceuticals

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1062-2016
FDA event ID: 74319
Recalling firm: Lyne Laboratories, Brockton, MA
Classification: Class III
Status: Terminated
Recall initiated: 7 Jun 2016
FDA classified: 5 Jul 2016
Reported: 13 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

7 Jun 2016	Recall initiated by company
5 Jul 2016	Classified by FDA	+28 days
13 Jul 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotency: product assayed and found OOS for cyproheptadine

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

New Jersey

Questions about this recall

Why was it recalled?

Subpotency: product assayed and found OOS for cyproheptadine

Which lots are affected?

Lot #: CR1603, Exp 12/17

Where was it sold?

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lyne Laboratories

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2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA

Other Cyproheptadine recalls

All 4

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalledCyproheptadine Hydrochloride	Rising Pharma Holding	Particulate Matter	Nationwide
19 Jun 2019Drug	CLASS II	Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg recalled	Torrent Pharma	Sterility	Nationwide
22 Jan 2014Drug	CLASS II	Cyproheptadine HCL Tablet, 4 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states