Recall Alert: Cyclobenzaprine Tablets May Contain Wrong Medication

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Unichem Pharmaceuticals has announced a voluntary recall of one lot of the muscle relaxer cyclobenzaprine hydrochloride tablets USP, 10 milligrams, because the bottles may actually contain meloxicam 7.5-milligram tablets (a prescription pain and arthritis medication). This labeling mistake could put patients at serious risk if they unknowingly take the wrong drug.

Taking meloxicam — a drug used to treat osteoarthritis, rheumatoid arthritis and juvenile arthritis — instead of cyclobenzaprine could lead to dangerous side effects, especially for people with certain health conditions. Possible risks include heart problems, stomach or intestinal bleeding, kidney damage, severe allergic reactions or serious skin reactions. People who are already taking nonsteroidal anti-inflammatory drugs (NSAIDs) or blood thinners or who have an allergy to meloxicam are at the highest risk.

So far, no adverse events have been reported, but patients should check their medication immediately. The recalled product can be identified by the following:

• Lot number: GMML24026A
• Expiration date: September 2027
• NDC: 29300-415-19

The mislabeled tablets can also be identified by appearance:

• Meloxicam (incorrect drug inside): Light yellow, round, flat, with “U & L” on one side and “7.5” on the other.
• Cyclobenzaprine (correct drug that should be inside): Blue, round, film-coated, with “U” on one side and “12” on the other.

The affected lot was distributed nationwide in 90-count bottles. Patients are advised to stop taking the medication if they have this lot number and return it to the pharmacy where it was purchased. Pharmacies have been instructed not to dispense bottles from this lot.

If you think you may have taken the wrong medication, contact your doctor right away. If you experience symptoms such as chest pain, stomach pain, severe allergic reactions or skin reactions, seek medical care immediately.

Patients can call Inmar at 1-877-840-5109 (Monday through Friday, 9 a.m.-5 p.m. Central time) or email rxrecalls@inmar.com with questions. Any side effects or problems should also be reported to the U.S. Food and Drug Administration (FDA)’s MedWatch program.