Lyne Laboratories Cyproheptadine Hydrochloride Syrup Recall

Why it was recalled

Subpotency: product assayed and found OOS for cyproheptadine

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: CR1603, Exp 12/17

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1062-2016
Classification: Class III
Status: Terminated
Recall initiated: Jun 7, 2016
FDA report date: Jul 13, 2016
Quantity: 12,215 Bottles shipped to Rising Pharmaceuticals
Recall type: Voluntary: Firm initiated
Recalling firm: Lyne Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-1062-2016, exactly as published.

Show all FDA fields

City: Brockton
State: MA
Status: Terminated
Country: United States
Event ID: 74319
Address: 10 Burke Dr
Code information: Lot #: CR1603, Exp 12/17
Postal code: 02301-5505
Report date: Jul 13, 2016
Product type: Drugs
Recall number: D-1062-2016
Classification: Class III
Recalling firm: Lyne Laboratories, Inc.
Product quantity: 12,215 Bottles shipped to Rising Pharmaceuticals
Termination date: Feb 3, 2017
Reason for recall: Subpotency: product assayed and found OOS for cyproheptadine
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: NJ
Recall initiation date: Jun 7, 2016
Initial firm notification: Letter
Center classification date: Jul 5, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1062-2016, published Jul 13, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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