Lyne Labs Recalls Cyproheptadine Syrup Due to Subpotency
Lyne Laboratories recalls Cyproheptadine Hydrochloride Syrup (Lot CR1603) because the drug content is lower than labeled. Check your bottle.
Use caution until it’s fixed
Subpotency: product assayed and found OOS for cyproheptadine
Contact the company
What happened, in plain English
Lyne Laboratories, Inc. is recalling Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL because it was found to be subpotent. The product assayed out of specification for cyproheptadine, meaning it may not contain the full amount of active ingredient listed on the label. This recall affects 12,215 bottles distributed to Rising Pharmaceuticals in New Jersey. Read more at govinfonow.com/recall/42591-lyne-labs-recalls-cyproheptadine-syrup-due-to-subpotency.
Source Summary by GovInfoNow · govinfonow.com/recall/42591-lyne-labs-recalls-cyproheptadine-syrup-due-to-subpotency · Updated October 9, 2026 · FDA enforcement record: FDA #D-1062-2016
Cite this page
“Lyne Labs Recalls Cyproheptadine Syrup Due to Subpotency.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42591-lyne-labs-recalls-cyproheptadine-syrup-due-to-subpotency. Based on FDA recall #D-1062-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1062-2016%22&limit=1).
Why it’s dangerous
The primary hazard is subpotency, meaning the syrup contains less cyproheptadine than stated on the label. For a prescription drug, this can lead to ineffective treatment of the condition it was prescribed for, as the patient does not receive the therapeutic dose they expect.
Who’s affected
Patients who have been prescribed Cyproheptadine Hydrochloride Syrup and possess the specific lot number CR1603 with an expiration date of 12/17. These individuals may be receiving a medication that is less potent than intended.
How to tell if you have this one
Look for an amber glass 473 mL (one pint) bottle with a child-resistant screw closure. The label must show NDC 64980-0504-48 and Lot # CR1603 with an expiration date of 12/17. The product was distributed by Rising Pharmaceuticals, Inc. in Allendale, NJ.
- Brand
Lyne Laboratories- Category
Drug
What to do — step by step
Check your medication label
Verify if your bottle matches Lot # CR1603 and has an expiration date of 12/17.
Contact your pharmacist or doctor
If you have the recalled lot, speak with your healthcare provider about next steps for replacement or adjustment.
Where it went and when
Where it was distributed
Distributed in New Jersey.
FDA distribution: “NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1062-2016 (June 7, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1062-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.